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A lot of money (Billions) was involved and it was to get vaccines on the street.
With Covid-19 still being a threat, there are still avenues available to fast track treatments to the market.
I couldn't tell you the odds of Sunshine Covid-19 treatment getting to the market however if their testing continues to show promise then it is certainly possible.
Currently, we are advancing the development of these two compounds in parallel with our SBFM-PL4 by conducting a transgenic mice study in collaboration with the University of Georgia. The mice being used in the study have been genetically engineered to express the human angiotensin-converting enzyme 2 (hACE2) transmembrane protein in their lungs making them susceptible to lethal infection by SARS-CoV-2, the causative agent of COVID-19. The SARSCoV-2 virus uses the hACE2 receptor to gain entry into human cells to replicate. The goal of the study is to determine if our protease inhibitors will protect the hACE2-transgenic mice from disease progression and death following infection with SARS-CoV-2 virus. Should these mice studies prove successful, we plan to submit the results to the FDA for authorization to conduct testing on actual COVID-19 patient volunteers in a Phase I clinical trial setting. The implications of a COVID-19 treatment becoming available are vast. This is particularly the case in view of the fact that some of the variants emerging around the world are more virulent and may escape neutralization by the current vaccines.
https://sunshinebiopharma.com/antiviral-drugs/
Yes you are correct Sunshine has done years of research.
I was referring to them going through the necessary clinical phases.
Sunshine Pharma is just getting started to move to HUMAN testing.
The testing they have been doing is preclinical studies which to date have been extremely positive.
What is next will determine just how solid these studies are.
Adva-27a Clinical Trials Plans
Adva-27a’s initial indication for Phase I clinical trials will be pancreatic cancer. We are planning to conduct our clinical trials at McGill University’s Jewish General Hospital in Montreal, Canada. All aspects of the planned clinical trials in Canada will employ FDA standards at all levels. We estimate that it will take approximately 18 to 24 months from start to finish. Following successful completion of Phase I clinical trials, it is likely that we will be required to make Adva-27a available to patients under the “compassionate-use” guidelines.
FDA drug approval pathway
Preclinical studies—animal models; safety profile
Investigational New Drug Application to conduct human trials submitted to FDA
Phase 1 Clinical Trial—safety profile, dosage
Phase 2a and 2b Clinical Trials—safety and efficacy
Phase 3 Clinical Trials—Pivotal large-scale studies to acquire data for FDA approval
New Drug Application for marketing product submitted to FDA
AdCom meetings—expert independent panelists review
PDUFA date—FDA decision on approving a drug for market
Traditionally, pharmaceutical product development companies must first perform preclinical work with animals to establish that the drug is safe before applying to conduct human clinical studies. The company can then submit an Investigational New Drug (IND) application to the FDA. Once the FDA has greenlighted human studies, the drug then must pass through three phases of clinical trials in which the company must obtain sufficient data to prove safety and efficacy.
At the conclusion of each clinical phase, the data is submitted to the FDA. The regulatory body will then make a decision as to whether or not the drug is a viable candidate for the next clinical phase. The completion of Phase 3 data moves the drug candidate to the final stage of the approval process, the Prescription Drug User Fee Act (PDUFA) meeting date.
This stock has to go through growing pains and proving pains.
There are many eyes on this stock such as Big Pharma, Institutional Investors and others.
What many don't understand is each entity has particular catalysts they would like to see before they commit their investment. Some of the catalyst may be the same and some different. These entities have different goals in mind, tolerance levels some their own research teams verifying the science.
Sunshine will move if the science is solid.
It one was to compare it to other stock making major moves one needs to determine at what Phase that particular stock was at.
Right now Sunshine is in the early stages and as they move through the different Phase and the science continue to be positive then the stockholders will be greatly rewarded.
Why would investors dump shares and cause pharma stock to plummet after FDA approval?
Biotech shares do tend to drop after getting FDA approval which sounds extremely counter intuitive. But there are a bunch of other factors that do go into valuations which do sort of explain this.
The most common explanation that I tend to find for a price drop is because investors tend to be more bullish on what the label will say. Generally speaking, the certainty going to FDA approval is pretty high. Most of the uncertainty will be what the approval will actually be for. Typically the most movement a stock will see isn’t around the approval date but around the advisory committee vote which occurs a few months prior to the FDA approval. A strong vote from the advisory committee gives good assurance that the drug would get approval which removes the biggest uncertainty around the company’s value.
Which brings us to the label. Once the uncertainty of the approval goes away, there is a lot of speculation on how wide the label extends. Investors will be bullish and hope that the drug can be given to nearly freaking everyone. More likely than not, the drug will be approved with certain limitations on indications, additional side effects, and certain post-market commitments to do follow-on trials to extend the label. All of those additions will decrease the value of the drug and ultimately the value of the stock.
Using one of the extreme examples let’s look at Biogen’s stock. Everyone knows about Biogen’s big drop due to the Alzheimer’s clinical trial failure. But a year earlier in July 2018, they made the announcement that they might have an Alzheimer’s drug which caused the price to pop. Their aducanumab Phase I results were presented back in 2016.
Biotech shares do tend to drop after getting FDA approval which sounds extremely counter intuitive. But there are a bunch of other factors that do go into valuations which do sort of explain this.
The most common explanation that I tend to find for a price drop is because investors tend to be more bullish on what the label will say. Generally speaking, the certainty going to FDA approval is pretty high. Most of the uncertainty will be what the approval will actually be for. Typically the most movement a stock will see isn’t around the approval date but around the advisory committee vote which occurs a few months prior to the FDA approval. A strong vote from the advisory committee gives good assurance that the drug would get approval which removes the biggest uncertainty around the company’s value.
Which brings us to the label. Once the uncertainty of the approval goes away, there is a lot of speculation on how wide the label extends. Investors will be bullish and hope that the drug can be given to nearly freaking everyone. More likely than not, the drug will be approved with certain limitations on indications, additional side effects, and certain post-market commitments to do follow-on trials to extend the label. All of those additions will decrease the value of the drug and ultimately the value of the stock.
Using one of the extreme examples let’s look at Biogen’s stock. Everyone knows about Biogen’s big drop due to the Alzheimer’s clinical trial failure. But a year earlier in July 2018, they made the announcement that they might have an Alzheimer’s drug which caused the price to pop. Their aducanumab Phase I results were presented back in 2016.
What is the true value of Biogen? Nothing practically changed about the drugs that they were selling between 2016–2019 but their stock fluctuated by nearly 50%. Everything was based on the perception of how big aducanumab and BAN2401 could be rather than how big they actually were. But these future looking evaluations are how stocks values are determined which is why they often move in opposite ways than how you would expect.
Key Stock Catalysts in the FDA Drug Application Process
Drug development in the US follows a standard process through which pharmaceutical and biotech companies advance a new drug candidate through nonclinical and clinical studies.
Once the company’s clinical data proves the drug is safe and effective, they can apply for market approval from the Food and Drug Administration (FDA). This is known as the FDA drug approval process.
As a drug candidate moves through each stage of the FDA regulatory approval pathway, there are several catalysts along the way that can represent significant value drivers for the company’s stock price. Tracking these inflection points can prove helpful to investors looking for opportunities in this space.
FDA drug approval pathway
Preclinical studies—animal models; safety profile
Investigational New Drug Application to conduct human trials submitted to FDA
Phase 1 Clinical Trial—safety profile, dosage
Phase 2a and 2b Clinical Trials—safety and efficacy
Phase 3 Clinical Trials—Pivotal large-scale studies to acquire data for FDA approval
New Drug Application for marketing product submitted to FDA
AdCom meetings—expert independent panelists review
PDUFA date—FDA decision on approving a drug for market
Traditionally, pharmaceutical product development companies must first perform preclinical work with animals to establish that the drug is safe before applying to conduct human clinical studies. The company can then submit an Investigational New Drug (IND) application to the FDA. Once the FDA has greenlighted human studies, the drug then must pass through three phases of clinical trials in which the company must obtain sufficient data to prove safety and efficacy.
At the conclusion of each clinical phase, the data is submitted to the FDA. The regulatory body will then make a decision as to whether or not the drug is a viable candidate for the next clinical phase. The completion of Phase 3 data moves the drug candidate to the final stage of the approval process, the Prescription Drug User Fee Act (PDUFA) meeting date.
Inflection points represent investment opportunities
Companies looking to raise capital often update investors as to the status of their drug candidates along the pathway to FDA market approval. A news release featuring great clinical study readouts can be the catalyst that triggers significant upward movement in the company’s share price. It’s these inflection points that really move a pharma or biotech stock.
So, which stages in the FDA approval process are likely to be the biggest drivers of shareholder value?
Positive early stage results offer some value
“As you advance your product through each of these steps, the product becomes de-risked in the eyes of investors,” Bob Farrell, president and CEO of Kalytera Therapeutics (TSXV:KALY,OTCQB:KALTF), told INN. “For example, when you complete preclinical studies, you have demonstrated that the product is safe enough in animals that it can now be tested in humans. Typically, you see a small bump up in share price at that time.”
Phase 1 human clinical testing, in which safety and proper dosage are studied, can be another inflection point for upward pressure on the stock. Positive Phase 1 data further de-risks a product by signaling the drug is ready for larger-scale testing.
For example, shares of iCo Therapeutics Inc. (TSXV:ICO) recently gained 33 percent after the company announced that it had begun its Phase 1 clinical study for Oral Amphotericin B for treatment of fungal and parasitic infections.
However, Farrell—who has more than 25 years of experience in the pharmaceutical, biotechnology and medical device sectors—says the more substantial inflection points come later as the drug progress through the final phases. “As you move toward the final goal of approval, it’s like moving up a staircase with each step representing the potential for a higher valuation and ultimately a higher share price,” he added.
Later-stage clinical results represent the sweet spot
The most significant value driving events are the conclusion of Phase 2 and Phase 3 clinical trials. This is where the real de-risking happens and the drug developer moves one step closer to submitting the new drug application (NDA) to the FDA for final market approval. Strong Phase 2 and Phase 3 data give investors confidence that the drug will receive that approval.
“Important trial data from Phase 2 and Phase 3 studies can produce extraordinary trading volume and price movement,” said George Mack, Managing Director of consulting firm BioDecade. “Trial results that tend to move shares are those that yield statistically significant data, which can only be derived from the randomized, double-blind experiments performed in Phase 2b and Phase 3 trials.”
An example of the value driving power of a good late-stage clinical readout is Sage Therapeutics (NASDAQ:SAGE) shares skyrocketed as much as 85 percent to hit a record high after announcing stellar Phase 2 results for the study of its drug candidate for the treatment of major depressive disorder.
Phase 3 testing typically involves large clinical trials that can be very expensive to conduct. It is not uncommon for small biotech firms to sell a Phase 2 product or license it to a big pharmaceutical company instead of advancing the product through Phase 3 themselves.
This is the strategy Kalytera plans to use in regards to its newly announced program in the treatment of acute and chronic pain using a novel CBD-based compound. Farrell says the drug developer will most likely “advance the product through Phase 1 and Phase 2 clinical testing, and if the product performs well — in other words synergistically and effectively relieving pain without the safety concerns seen with opioids — at that point we will potentially have a very valuable program that we can then license or sell to a major pharmaceutical partner within a few short years.”
Final stage inflection points
Phase 3 data forms the basis for a company’s NDA in which it formally seeks final market approval from the FDA. Once a drug developer submits the application, the FDA will announce the PDUFA meeting date—the day the regulatory body with give its final decision to approve or not approve the new drug. In the lead up to the PDUFA date, the FDA may hold Advisory Committee (AdCom) meetings in which independent panelists give yay or nay expert opinions on whether the FDA should allow the drug to go to market.
The submission of the NDA, AdComs and the FDA’s announcement of the PDUFA date represent the final steps in the regulatory pathway. News releases on these critical milestones can make quite an impression on investors and a significant impact on share prices.
https://investingnews.com/daily/life-science-investing/biotech-investing/tracking-key-stock-catalysts-in-the-fda-drug-approval-process/
You are very persistent, very determined and very appreciated for your efforts. Many here are just as excited and protective of our company.
QNTA has some powerful technology that just has to go through the motions before it is unleashed as never seen before in the Pharmaceutical community.
May 22, 2021, the registrant had 176,458,527 shares of Common Stock outstanding.
The have the right day however the wrong date.
It should have been May 25.
The company should put a correction.
Facts are Facts.
Peptides use are on the rise not only for QNTA but throughout the Pharmaceutical community and have been in recent years.
One of the main components of Escozine™ is a 36 amino acid peptide, which at pH 7 has a high positive charge. It blocks small-conductance chloride channels, and it also binds preferentially to abnormal cells, leaving the normal cells intact.
The growing significance of peptide therapeutics
The therapeutic use of peptides lags behind that of proteins. And there are good reasons for this. However, it seems that this is beginning to change and that peptide therapeutics are growing in significance. As a matter of fact, peptides have become rather popular candidates for drugs.
There is a rich source of peptide therapeutics; they can be mined from a variety of unicellular and multicellular organisms as well as from recombinant and chemical libraries. Peptides offer a chemical diversity greater than that of any other class of biological molecule. Closely related analogues increase the diversity still further.
Many challenges
“The use of peptides as drugs is associated with many challenges,” says Tanja Weil, a chemist with many years of pharmaceutical experience. Many researchers share Weil’s opinion. The list of challenges is rather long. Challenge number one: peptides need to be delivered via injection because oral administration would lead to their degradation in the digestive tract. Challenge number two: they have a short half-life because they are quickly broken down by proteolytic enzymes in the digestive tract. Challenge number three: they are relatively quickly cleared from the blood circulation by the liver and kidneys. Challenge number four: their hydrophilic nature prevents them to a large extent from getting past physiological obstacles. Challenge number five: their pronounced conformational flexibility sometimes leads to a lack of selectivity, the activation of different cell structures and adverse effects.
“For pharmaceutical researchers peptides used to be a ‘no go’ area,” says Weil. However, the bias against peptides as pharmaceutical agents has changed and important advantages have come to the fore. Despite their disadvantages, peptides have several advantages over small molecule drugs. They are naturally occurring biologics and hence safer than synthetic drugs and have a greater efficacy, selectivity and specificity. Peptides possess bioactivities that are of major interest for drug discovery; peptides, peptide fragments, amino acids or proteins control and coordinate most physiological processes. In contrast to synthetic substances, peptides are degraded into their component proteinogenic amino acids without leading to toxic metabolites. Tanja Weil believes that this is the reason why the bias against peptides as pharmaceutical agents is fading. In addition, a disadvantage can also be an advantage: although short half-lives make peptide drugs costly on the one hand, the advantage of short half-lives is that peptide drugs are associated with less accumulation in the body, thereby reducing the risks that might arise from their degradation products. Compared with larger proteins and antibodies, peptides can penetrate further into tissue. Moreover, they are generally less immunogenic than recombinant proteins and antibodies. In addition, they are associated with lower manufacturing costs, higher activity and greater stability (they can be stored at room temperature). Many therapeutic peptides are derived from natural proteins or polypeptides and tend to interact with membrane proteins. Usually, tiny quantities of peptides are sufficient to activate or deactivate the target receptors. Only a handful of peptide antagonists that compromise ligand-receptor interactions have been placed on the market. In general, peptide antagonists need to occupy more than half of the targeted receptors in order to exert their effect; peptide agonists can do so by occupying as little as five to 20 percent.
An increasing number of peptide drugs is being placed on the market
Many of the peptide drugs on the market are peptide hormones or peptide derivatives that stimulate hormone action. The number of peptide drugs being placed on the market has been increasing since 2000. A highlight and temporary peak was in 2012 when six peptide drugs were placed on the American market and five on the European market. However, one of the drugs was withdrawn from the American market in 2013. An injectable GLP-1R agonist (lixisenatide) was approved by the European Commission for the treatment of type 2 diabetes in 2013; a synthetic peptide hormone (afamelanotide) with the ability to prevent the occurrence of skin cancers is currently undergoing EMA review and results are expected by mid-2014. As early as in 2006, a recombinant human parathyroid hormone (Preotact) with the potential to prevent vertebral fracture in postmenopausal women was placed on the market.
Around a dozen or so peptide drugs are currently undergoing advanced clinical testing. The peptide therapeutics that are already on the market target a broad range of indications and are administered either intravenously, subcutaneously, by inhalation and even orally (linaclotide). The majority of the 120 peptide drugs that are currently undergoing clinical testing target indications in oncology and infectious diseases. More than 50% of all peptide drug candidates target a single target structure and about 10% target microbes. The most frequent targets of peptide drugs are membrane proteins, especially G protein-coupled receptors (almost 40% according to Kaspar/Reichert) that reside in the outer cell membrane and transfer external signals into the interior of the cells. Peptides undergoing clinical phase II testing frequently have a wide range of structural changes (e.g. they are linked to lipids or PEG). The fact that peptides represent around half of all drug candidates in phase I clinical testing over the last two years is seen as evidence of the growing importance of peptide drugs for the treatment of human disease.
Improving stability and function
“The oral administration of peptides is still a ‘Holy Grail’ of pharmaceutical research,” says Weil, also highlighting that new technologies have succeeded in breaking down the barrier to using peptide drugs. The pharmaceutical industry is working hard to find solutions that allow the oral administration of insulin in such a way that it is not rapidly degraded in the gastrointestinal tract. However, all attempts are still experimental and no marketable product is in sight. Many researchers are working on optimising the delivery of the drug and Tanja Weil is convinced that the cooperation between medical doctors and scientists, which also involves the use of high-throughput omics technologies (e.g. proteomics, metabolomics), has led to considerable progress in peptide research.
“In Ulm, we have access to a large number of peptides with a huge chemical diversity. So the chance of matching a peptide to a physiological target is quite good. Peptides are interesting drug candidates because they carry numerous functional groups that can be altered chemically. We are therefore able to synthesize peptides that nature is unable to produce and that have improved properties,” summarizes the chemist from Ulm.
Weil uses the amino acid cysteine as an example to explain why peptides have become popular targets of drug discovery approaches. Cysteine is a sulphur-containing natural amino acid. Cysteines can form disulphide bonds, thereby boosting their stability. “This is chemistry par excellence,” says Weil explaining that it is possible to induce a particular reaction between an organic molecule and a cysteine molecule. When incorporated at a particular site, cysteine also has the ability to connect peptides with each other. Weil believes that this approach has the potential to produce a functional protein in vitro. Although the ability to create an enzyme in the test tube is still a pipe dream, the potential is no doubt there.
Optimizing makes progress
Weil believes that some peptide optimization strategies have already achieved a certain maturity: for example, animal experiments are being carried out with encapsulated peptide drugs which are expected to survive the journey through the digestive tract. It has been shown that mesoporous silica particles are suitable for encapsulating peptides and subsequently releasing them into the blood. Other approaches involve the attachment of polymers such as polyethylene glycol groups to peptide drugs (PEGylation). Here, polymers that do not adsorb very well to plasma proteins are used; the drugs remain longer in the blood and can reach suitable cellular surface receptors.
Other researchers concentrate on approaches focused on increasing peptide stability by adding residues that are not so easily recognized by enzymes. It has been shown that the proteolytic degradation of peptide drugs can be slowed down by substituting L-type amino acids with D-type amino acids which are less susceptible to proteolytic degradation and therefore effective for longer. Only recently, research groups led by Münch, Kirchhoff and Weil succeeded in identifying and characterizing a peptide that forms visible aggregates and considerably improves the transport of viruses into cells. This approach might also be of interest for application in gene therapy. “There are some highly promising approaches, including here in Ulm. Research in this area has made greater progress than research related to the oral bioavailability of the peptide drugs,” says Weil.
New stars among biologics?
Biologics such as peptides are gaining in importance due to their high specificity and biological activity, especially given that small molecule drugs are expensive, often produce toxic metabolites and are associated with unwanted interactions.
Due to the availability of advanced optimization strategies, peptide drugs have meanwhile become an attractive substance class that is suitable for producing semi-synthetic drugs for treating CNS (Vlieghe, 54) and other diseases. Peptide drugs are already being tested for their efficacy in treating cancer and inflammation as well as for their potential as antibiotic and enzyme inhibitors. Antimicrobial peptides are predicted to have a great future.
The search for active drug ingredients in nature is not a new idea in itself, what is new is that researchers are looking for them in human body fluids. “This approach might be a good choice as their isolation and purification is usually rather difficult,” says Weil. It goes without saying that peptides produced by the human body have a toxicological profile that is far removed from that of exogenous substances that are extracted from sponges or of cytotoxic substances derived from tree bark.
Researchers from Ulm and elsewhere are of the opinion that the degradome, i.e. all proteins degraded by proteolytical enzymes, is not biological waste and not a hazard. This is because the large number of proteases (> 500) that cut proteins into peptide fragments could potentially be altered under pathological conditions. In addition, there is growing evidence that some of the cleavage products of larger proteins have a specific, and sometimes unexpected, reaction against human pathogens.
It seems likely that the human organism harbours important peptide immune modulators and effectors. A dozen therapeutically interesting peptides with antimicrobial and anti- or proviral activity have been identified in human peptide libraries (Münch, Ständker, 15). Not all peptides isolated from body fluids are worth developing into drug leads. However, the researchers from Ulm are happy about any new finding they make as they hope that insights into the regulation of cells and the uptake of peptide drugs into cells will improve their current knowledge and potentially also lead to the discovery of completely new mechanisms of action and defence.
Hopefully not.
The Press Release is in reference to First Quarter 2021 which is January 1, 2021 to March 31, 2021.
They first filed the IND application in January with a follow up in April.
Hopefully someone will ask the question at the conference call.
QNTA is Delinquent in filing the 10Q.
They did file a NT 10-Q however they failed to file within the 5 day extension and therefore the yield sign is up until they file the 10Q.
This has happened in the past and the company eventually filed the 10Q.
So although it is a bit concerned it is a minor hiccup and it will eventually get done.
PetLife Pharmaceuticals and its sister company, Medolife, are the only companies in the world with the patented Escozine formulation based upon Blue Scorpion Venom. Escozine For Pets™ is solely owned and commercialized by PetLife Pharmaceuticals.
PetLife Founder and CEO Arthur Mikaelian, Ph.D. is the scientist who completed the R&D and attained the legal registration to commercialize the Blue Scorpion venom-based product under the name of Escozine For Pets.
Escozine™ and Escozine for Pets utilize the licensed, patented polarization technology which produces a far more effective product than Labiofams's Blue Scorpion venom in Escozul and Vidatox.
PetLife, in affiliation with Medolife, has its own independent source of Blue Scorpion venom in the Dominican Republic, the world's first Scorpion reservation of 50,000 square meters that can produce millions of doses to meet global demand.
The world renowned Atheris Laboratory in Switzerland has provided scientific confirmation to Medolife that Blue Scorpion venom blocks sodium and potassium volt gate channels. This action causes actual shrinkage of tumors and inhibits cancer cell proliferation.
The report indicates that Dominican Blue Scorpion venom has a three times higher concentration of Chlorotoxin (CLTX) -- which is one of the main components with anti-tumoral properties and also has smaller molecular weight -- than the Cuban blue scorpion venom. This high concentration of CLTX makes Escozine For Pets™ more effective in the penetration of cancer cell membranes as well as the blood-brain barrier.
https://finance.yahoo.com/news/petlife-publishes-two-white-papers-153100867.html
That is for regular drug approval.
Within regular drug approval there is:
Drug Development Designations
The agency also employs several approaches to encourage the development of certain drugs, especially drugs that may represent the first available treatment for an illness, or ones that have a significant benefit over existing drugs. These approaches, or designations, are meant to address specific needs, and a new drug application may receive more than one designation, if applicable. Each designation helps ensure that therapies for serious conditions are made available to patients as soon as reviewers can conclude that their benefits justify their risks.
Fast Track is a process designed to facilitate the development and advance the review of drugs that treat serious conditions, and fill an unmet medical need, based on promising animal or human data. Fast tracking can get important new drugs to the patient earlier. The drug company must request the Fast Track process. More information about the Fast Track process is here.
Breakthrough Therapy designation expedites the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy. A drug with Breakthrough Therapy designation is also eligible for the Fast Track process. The drug company must request a Breakthrough Therapy designation. More information about Breakthrough Therapy designation is here.
Priority Review means that FDA aims to take action on an application within six months, compared to 10 months under standard review. A Priority Review designation directs attention and resources to evaluate drugs that would significantly improve the treatment, diagnosis, or prevention of serious conditions. More information about Priority Review is here.
INDs are a different ballgame:
Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
FDA's role in the development of a new drug begins when the drug's sponsor (usually the manufacturer or potential marketer), having screened the new molecule for pharmacological activity and acute toxicity potential in animals, wants to test its diagnostic or therapeutic potential in humans. At that point, the molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and becomes a new drug subject to specific requirements of the drug regulatory system.
There are three IND types:
An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.
Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR , Sec. 312.23 or Sec. 312.20. It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.
Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.
There are two IND categories:
Commercial
Research (non-commercial)
The IND application must contain information in three broad areas:
Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).
Manufacturing Information - Information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators--professionals (generally physicians) who oversee the administration of the experimental compound--to assess whether they are qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
Does have any updated information as to when the quarterly report is going to be released?
I sent a request to IR and am awaiting a response.
Time Period:Jan 4, 2021 - May 17, 2021Show: QNTA Historical Prices Frequency:Daily
The Highest and Lowest Closing prices are colored.
QNTA has been drifting down since a close of 0.1377 on May 12, 2021.
It will reverse eventually as it has done in the past however it may do so powerfully with pending news on the horizon.
There are many catalysts that Quanta in the works with updates coming at anytime:
Quanta for 2021 will be undergoing a name change to be announced shortly as well as Quanta is in the process of expanding its product line from 4 SKUs to 38 by summer. We will also be introducing all new branding with new color schemes, new packaging, and exciting celebrity endorsements for the pain relief products and a newly introduced beauty product line. Quanta will also be working on a men’s cosmetic line in conjunction with one of the celebrity endorsements planned for late 2021. The company has hired an advertising agency to help with the rollout of the new branding expected second quarter 2021. This will work in conjunction with a major push the company is on the path of with some major big box retail chains.
Date Open High Low Close* Adj Close** Volume
May 17, 2021 0.1300 0.1300 0.0954 0.0990 0.0990 6,206,825
May 14, 2021 0.1390 0.1390 0.0920 0.1238 0.1238 9,964,431
May 13, 2021 0.1440 0.1680 0.1060 0.1200 0.1200 15,376,610
May 12, 2021 0.0875 0.1450 0.0851 0.1377 0.1377 22,395,854
May 11, 2021 0.0771 0.1090 0.0671 0.0930 0.0930 18,140,553
May 10, 2021 0.0800 0.0825 0.0732 0.0761 0.0761 12,135,047
May 07, 2021 0.0850 0.0900 0.0772 0.0785 0.0785 12,279,541
May 06, 2021 0.1100 0.1110 0.0809 0.0844 0.0844 13,055,901
May 05, 2021 0.0959 0.1100 0.0810 0.0945 0.0945 19,684,768
May 04, 2021 0.1600 0.1675 0.0960 0.1020 0.1020 21,755,324
May 03, 2021 0.1700 0.1852 0.1303 0.1406 0.1406 23,459,182
Apr 30, 2021 0.0700 0.2050 0.0680 0.1951 0.1951 71,773,823
Apr 29, 2021 0.0595 0.0700 0.0560 0.0667 0.0667 11,508,233
Apr 28, 2021 0.0500 0.0560 0.0460 0.0550 0.0550 5,005,492
Apr 27, 2021 0.0510 0.0510 0.0465 0.0490 0.0490 2,285,823
Apr 26, 2021 0.0500 0.0525 0.0450 0.0474 0.0474 5,690,663
Apr 23, 2021 0.0490 0.0540 0.0465 0.0470 0.0470 4,991,548
Apr 22, 2021 0.0530 0.0530 0.0483 0.0489 0.0489 1,653,095
Apr 21, 2021 0.0653 0.0653 0.0476 0.0505 0.0505 7,078,759
Apr 20, 2021 0.0619 0.0770 0.0500 0.0590 0.0590 7,274,688
Apr 19, 2021 0.0661 0.0661 0.0450 0.0534 0.0534 3,573,998
Apr 16, 2021 0.0700 0.0700 0.0510 0.0622 0.0622 1,933,048
Apr 15, 2021 0.0790 0.0790 0.0510 0.0695 0.0695 5,961,942
Apr 14, 2021 0.0700 0.0800 0.0600 0.0661 0.0661 5,136,961
Apr 13, 2021 0.0700 0.0860 0.0600 0.0651 0.0651 10,482,628
Apr 12, 2021 0.0420 0.0600 0.0420 0.0550 0.0550 7,637,428
Apr 09, 2021 0.0480 0.0480 0.0403 0.0415 0.0415 8,179,655
Apr 08, 2021 0.0698 0.0874 0.0450 0.0450 0.0450 29,107,348
Apr 07, 2021 0.0460 0.0460 0.0410 0.0429 0.0429 395,756
Apr 06, 2021 0.0419 0.0487 0.0400 0.0440 0.0440 851,316
Apr 05, 2021 0.0485 0.0485 0.0400 0.0400 0.0400 1,619,054
Apr 01, 2021 0.0441 0.0550 0.0420 0.0485 0.0485 2,151,084
Mar 31, 2021 0.0405 0.0420 0.0390 0.0420 0.0420 891,875
Mar 30, 2021 0.0476 0.0500 0.0391 0.0398 0.0398 6,131,198
Mar 29, 2021 0.0498 0.0498 0.0400 0.0421 0.0421 1,583,179
Mar 26, 2021 0.0599 0.0620 0.0465 0.0500 0.0500 3,107,152
Mar 25, 2021 0.0505 0.0700 0.0402 0.0578 0.0578 5,644,237
Mar 24, 2021 0.0710 0.0710 0.0512 0.0531 0.0531 4,706,680
Mar 23, 2021 0.0640 0.1000 0.0590 0.0680 0.0680 12,180,803
Mar 22, 2021 0.0529 0.0591 0.0500 0.0520 0.0520 3,166,312
Mar 19, 2021 0.0770 0.0810 0.0529 0.0591 0.0591 6,126,853
Mar 18, 2021 0.0510 0.1400 0.0476 0.0700 0.0700 26,067,619
Mar 17, 2021 0.0550 0.0550 0.0400 0.0420 0.0420 1,837,140
Mar 16, 2021 0.0600 0.0950 0.0475 0.0570 0.0570 2,744,299
Mar 15, 2021 0.0578 0.0605 0.0520 0.0535 0.0535 2,111,444
Mar 12, 2021 0.0670 0.0670 0.0580 0.0580 0.0580 663,176
Mar 11, 2021 0.0639 0.0690 0.0639 0.0654 0.0654 292,319
Mar 10, 2021 0.0735 0.0735 0.0641 0.0671 0.0671 418,005
Mar 09, 2021 0.0800 0.0800 0.0698 0.0700 0.0700 527,656
Mar 08, 2021 0.0800 0.0800 0.0750 0.0775 0.0775 1,816,776
Mar 05, 2021 0.0800 0.0800 0.0640 0.0700 0.0700 495,748
Mar 04, 2021 0.0723 0.0800 0.0700 0.0800 0.0800 123,185
Mar 03, 2021 0.0800 0.0800 0.0710 0.0723 0.0723 109,313
Mar 02, 2021 0.0730 0.0825 0.0641 0.0707 0.0707 137,396
Mar 01, 2021 0.0840 0.0840 0.0730 0.0730 0.0730 59,704
Feb 26, 2021 0.0829 0.0830 0.0730 0.0746 0.0746 183,599
Feb 25, 2021 0.0828 0.0829 0.0759 0.0828 0.0828 37,578
Feb 24, 2021 0.1000 0.1000 0.0700 0.0839 0.0839 21,666
Feb 23, 2021 0.0776 0.0889 0.0650 0.0700 0.0700 535,017
Feb 22, 2021 0.0625 0.0890 0.0611 0.0746 0.0746 205,958
Feb 19, 2021 0.0723 0.0820 0.0650 0.0660 0.0660 140,499
Feb 18, 2021 0.0805 0.0889 0.0650 0.0725 0.0725 399,928
Feb 17, 2021 0.1000 0.1000 0.0850 0.0880 0.0880 69,218
Feb 16, 2021 0.1000 0.1000 0.0900 0.0900 0.0900 142,287
Feb 12, 2021 0.0860 0.1000 0.0860 0.0901 0.0901 90,007
Feb 11, 2021 0.1190 0.1190 0.0850 0.0990 0.0990 246,185
Feb 10, 2021 0.1290 0.1290 0.0860 0.0863 0.0863 350,862
Feb 09, 2021 0.1300 0.1300 0.0881 0.0900 0.0900 350,248
Feb 08, 2021 0.0997 0.1400 0.0760 0.0975 0.0975 203,567
Feb 05, 2021 0.0980 0.0985 0.0900 0.0943 0.0943 102,904
Feb 04, 2021 0.0990 0.0990 0.0810 0.0950 0.0950 261,556
Feb 03, 2021 0.0990 0.0990 0.0800 0.0898 0.0898 282,612
Feb 02, 2021 0.1517 0.1517 0.0600 0.0900 0.0900 1,270,463
Feb 01, 2021 0.1300 0.1596 0.1100 0.1250 0.1250 295,096
Jan 29, 2021 0.0993 0.1650 0.0993 0.1499 0.1499 847,046
Jan 28, 2021 0.0950 0.1040 0.0950 0.1018 0.1018 572,732
Jan 27, 2021 0.0890 0.1000 0.0850 0.0962 0.0962 527,763
Jan 26, 2021 0.0775 0.0803 0.0752 0.0800 0.0800 40,008
Jan 25, 2021 0.0830 0.0830 0.0800 0.0830 0.0830 105,594
Jan 22, 2021 0.0830 0.0830 0.0812 0.0830 0.0830 23,511
Jan 21, 2021 0.0825 0.0890 0.0800 0.0850 0.0850 629,428
Jan 20, 2021 0.0700 0.0750 0.0700 0.0728 0.0728 74,915
Jan 19, 2021 0.0629 0.0660 0.0620 0.0660 0.0660 78,518
Jan 15, 2021 0.0628 0.0630 0.0600 0.0629 0.0629 93,294
Jan 14, 2021 0.0550 0.0600 0.0550 0.0600 0.0600 17,400
Jan 13, 2021 0.0627 0.0627 0.0600 0.0600 0.0600 12,550
Jan 12, 2021 0.0533 0.0604 0.0533 0.0604 0.0604 37,200
Jan 11, 2021 0.0644 0.0644 0.0551 0.0551 0.0551 49,283
Jan 08, 2021 0.0591 0.0635 0.0555 0.0570 0.0570 163,187
Jan 07, 2021 0.0560 0.0608 0.0520 0.0608 0.0608 207,252
Jan 06, 2021 0.0560 0.0644 0.0560 0.0607 0.0607 15,450
Jan 05, 2021 0.0600 0.0620 0.0561 0.0561 0.0561 23,749
Jan 04, 2021 0.0650 0.0650 0.0560 0.0560 0.0560 158,467
Medolife", a majority owned subsidiary of Quanta, Inc. has been very busy since the first of the year as they conducted quite a bit of research and testing of their products. They are on the verge of becoming a significant player in providing solutions to some of the world's most debilitating diseases. Medolife have made great strides thus far however they are striving to reach greater milestones as the prepare for human clinical trials in the United States and beyond.
Onward and Upward will be the trend.
January 27, 2021
Medolife's Therapeutic Scorpion Peptide Proves Successful in Treating COVID-19 Patients in Dominican Republic Study
After the successful study, Escozine® is on fast-track to be registered with the Ministry of Health in the Dominican Republic in Q1 2021. Medolife also submitted the study data to the US FDA, which is currently under review for permission to repeat the clinical trial in the United States. In addition to supporting the recovery of COVID-19 patients, Escozine® was registered and certified for cancer treatment by the Ministry of Health in the Dominican Republic in 2010.
https://finance.yahoo.com/news/medolifes-therapeutic-scorpion-peptide-proves-135700420.html?.tsrc=rss
February 23, 2021
Medolife Rx And CURE Pharmaceutical Holding Corp. Collaborate For A Significant Increase Of Revenue
New Production Platform
Under the terms of the Collaboration and Joint Development Agreement, Medolife is investing into CURE to increase their production capabilities, while Medolife is receiving a production platform at CURE's manufacturing facility, located in Oxnard, California. This platform will be used for Medolife's pharmaceutical-grade products, such as their COVID-19 therapeutic, which is currently a US FDA Pre-Investigational New Drug (PIND #150335). In addition, Medolife is preparing for a US FDA application for their pancreatic cancer drug and a CBD topical cream to treat muscle pain, which will be produced within CURE's facility. More pharmaceutical-grade formulations are planned to follow.
Fully Licensed Facility
CURE's manufacturing facility currently holds production licenses for pharmaceuticals, nutraceuticals and cannabinoid-based products. It is also cGMP certified by the National Sanitation Foundation ("NSF") and adheres to the highest standards of quality. With the new production platform at CURE's manufacturing facility, Medolife can produce a wide variety of products, such as Medolife's COVID-19 therapeutic, cancer drugs and nutraceuticals like immune system enhancers, cosmetics, nootropics, stress relievers, and cannabinoid-based products.
https://finance.yahoo.com/news/medolife-rx-cure-pharmaceutical-holding-135600501.html?.tsrc=rss
March 09, 2021
Medolife Rx Announces Preclinical Trial Results From Toxicity Study on Lead Drug Candidate
Medolife Rx, Inc. ("Medolife"), a majority owned subsidiary of Quanta, Inc. (OTC PINK: QNTA), announced today preclinical trial results on its lead drug candidate Escozine®, a proprietary formulation consisting of small molecule peptides derived from Rhopalurus princeps scorpions, which is amplified by the Company’s polarization technology and is being researched as a treatment for various indications including the SARS-CoV-2 (COVID-19) virus and certain cancers. The preclinical trial concluded that at maximum dose levels the product is non-toxic and safe.
The study, which was completed through a third-party contract research organization (CRO) located in California under strict medical guidelines, was conducted in two phases on BALB/c mice. The first phase was completed on 12 mice where the mice were given the drug candidate at a 26 µg/kg dose volume and monitored for 24 hours. At the conclusion of the first phase, researchers did not observe any significant abnormalities. In the second phase, the same dose of the drug candidate was administered daily over the course of 14 days where researchers also observed no significant abnormalities in clinical observations, body weight, necropsy observation, hematology, and clinical chemistry. These observations rendered a study result that the candidate is well-tolerated in mice and thus is proven safe and non-toxic.
“This study was a major first step in our clinical research programs across the world and having proven that the potential drug is safe in mice opens up the research pipeline for further trials and potential market approval,” said Medolife CEO Dr. Arthur Mikaelian. “Whenever you are working with new and novel therapeutics, both regulatory bodies and researchers want to be absolutely certain that the candidate is non-toxic before moving into human trials. This result will provide the foundation for which we can propel our research into humans, which we have already begun doing in the Dominican Republic and other countries around the world. This study data was also used in our pre-investigational new drug filing with the US Food and Drug Administration (FDA).”
This drug candidate utilizes Medolife’s patented polarization technology, which increases the potency of single molecules and complex compounds. This technology is already used in various Medolife products, ranging from supplements to drug candidates where the company is currently involved in a variety of clinical programs, including the Escozine® program. This program targets first product registration in the Dominican Republic for treatment of COVID-19 where the Company has already completed a human trial on safety and efficacy.
https://finance.yahoo.com/news/medolife-rx-announces-preclinical-trial-140000084.html?.tsrc=rss
March 16, 2021
MedolifeRx Announces Results From Efficacy Test on Polarization Technology Showing 497 Percent Increase in Efficacy of API When Polarized
Medolife Rx, Inc. ("Medolife"), a global integrated bioceutical company with R&D, manufacturing and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. (OTC PINK: QNTA), announced today results from an independent efficacy test conducted on the Company’s polarization technology where the subject compound showed an increased efficacy of 497 percent when compared to its non-polarized counterpart, validating the polarization technology that is being used in most of Medolife’s clinical programs and consumer products.
The results showed that polarization of Kratom demonstrates sufficient polarizability, which is the ability of compounds to absorb photon emission through electromagnetic resonance. The ATP production in the primary human fibroblast cells of the Polarized Kratom sample is 497 percent higher than the Non-Polarized Kratom sample.
The study is important to the Company’s overall pharmaceutical and nutraceutical product research and development programs as most of the Company’s products utilize the polarization technology, which was designed to increase the potency of single molecules and complex compounds. This study further validates the technology and positions the Company for further research to increase the effectiveness of various APIs, decreasing side effects of harsh compounds as well as the raw material input of medicines and nutraceutical products.
Medolife’s lead clinical development programs include Escozine®, a proprietary formulation consisting of small molecule peptides derived from Rhopalurus princeps scorpions, which is amplified by the Company’s polarization technology and is being researched as a treatment of various indications, including COVID-19 and cancer. The Company recently announced results from a toxicity study on the drug candidate that showed that at maximum dose levels the product is non-toxic and safe. The Company is seeking product registration for the treatment of COVID-19 in the Dominican Republic and has filed study data in pre-IND format with the US FDA.
https://finance.yahoo.com/news/medoliferx-announces-results-efficacy-test-130000011.html?.tsrc=rss
March 23, 2021
Medolife Rx Announces Pre-Clinical Results on Drug Candidate Escozine Showing Efficacy in Eliminating Cell Lines in Ovarian and Bladder Cancer
Medolife Rx, Inc. ("Medolife"), a global integrated bioceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. (OTC PINK: QNTA), announced today clinical trial results conducted on its lead drug candidate Escozine® where the drug eradicated in vitro bladder (SCaBER) and ovarian (OVCAR-3 and IGR-OV1) cancer cell lines when administered for 24 hours.
The study was conducted at one of the most prestigious academic research facilities in the United States. The goal of the study was to assess the viability of human bladder and ovarian cancer cells treated with Escozine®, the Company’s polarized drug candidate derived from a small molecular peptide found in scorpions. It examined the effects of both polarized and non-polarized versions of the drug on the viability of cell walls, finding that only the polarized version had a significant effect on eliminating the cell lines in all three cancers. This highlights not only the potential of Escozine® as a treatment for cancer, but the increased efficacy and bioavailability of the drug through the polarization methodology unique to Medolife Rx. Cell lines are commonly used in in vitro model systems in many drug discovery research programs. They retain most of the genetic properties of the cancer of origin and provide researchers with an indefinite source of biological material for experimental purposes (source). This study was especially significant in that Escozine® eradicated the cell lines completely, furthering the hypothesis that the drug could eliminate cancer cells in humans completely as well.
“We could not be more pleased by the results of this research,” said Medolife CEO Dr. Arthur Mikaelian. “As we progress in our clinical research on Escozine®, where we are initially targeting product registration and approval for treatment of COVID-19, we are conducting ongoing research on its potential therapeutic benefits as a treatment for various other indications, including many types of cancer. In this study, our drug completely eliminated the cell lines of two types of cancer in three samples. These results are not just exciting, they could be the precipice for what could become an effective treatment for one of the largest health issues in the world. Beyond proving the peptides’ ability to eradicate cancer cell lines, the study also showed how effective our polarization technology is on increasing efficacy. With results like these, I could not be more confident in Escozine® as a viable treatment for a variety of health issues and we are so proud to continue to push it through clinical trials around the world.”
The Company is conducting concurrent clinical studies on Escozine® around the world in countries such as the Dominican Republic and the United States. It is seeking product registration in the Dominican Republic for treatment of COVID-19, where it recently announced positive efficacy and safety results on over 500 patients. Additionally, it has filed data on Escozine® with the US Food and Drug Administration (FDA) as a Pre-Investigational New Drug (PIND #150335) as a COVID-19 therapeutic and is hoping to receive a response in short order. Medolife utilizes a patented polarization technology in all of its clinical drug candidates and nutraceutical consumer products that increase the potency of single molecules and complex compounds.
https://finance.yahoo.com/news/medolife-rx-announces-pre-clinical-130000576.html?.tsrc=rss
March 25, 2021
Medolife Rx Completes Batch Production of Escozine® for FDA Submission
Medolife Rx, Inc. ("Medolife"), a global integrated bioceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. (OTC PINK: QNTA), announced today that it has completed production of a batch of its lead drug candidate Escozine® and finalized analysis of the batch, which is now ready for submission to the US Food and Drug Administration (FDA) as a part of its Pre-Investigational New Drug (PIND #150335) filing as a potential treatment for the SARS-CoV-2 (COVID-19) virus.
As a part of its previously announced filing with the FDA on Escozine®, which is a polarized solution of the Rhopalurus princeps scorpion peptide owned by Medolife, the Company was asked to produce a batch of the drug for further investigation by the agency. As such, Medolife produced the batch and performed analysis on it, confirming its microbiology and inclusion of its main ingredient. After successful completion of the analysis, the Company is now prepared to submit the batch according to the FDA’s request, moving the Company closer to FDA registration of the drug through the IND regulatory process. The Company hopes to complete the submission in the coming week.
https://finance.yahoo.com/news/medolife-rx-completes-batch-production-130000438.html?.tsrc=rss
March 30, 2021
Medolife Rx Furthers Expansion of Scorpion Reservation; Prepares for Mass Production of Escozine Required Upon Product Registration
Medolife Rx, Inc. ("Medolife"), a global integrated bioceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. (OTC PINK: QNTA), announced today that it has furthered the expansion of its scorpion reservation located in the Dominican Republic (“DR”). The first-of-its-kind location has been expanded by approximately 6,350 square meters where the Company will be able to safely and humanely cultivate scorpions of various types for the extraction of the peptides necessary to produce its lead clinical drug candidate Escozine®, which is currently awaiting product registration for the treatment of the SARS-CoV-2 (COVID-19) virus in the region.
Upon product registration in the DR, Medolife estimates demand for Escozine® could be upwards of one million doses in the first quarter after registration. The Company is actively scaling up cultivation of the peptide in order to meet this demand, as well as planning an additional expansion to the reservation in the form of a medical lab facility on the premises, which would decrease logistical costs in the Escozine® production process. Beyond its pending product registration in the DR, data on Escozine® has been submitted to the US Food and Drug Administration (FDA) through the Investigational New Drug regulatory pathway, which, if approved, would make Escozine® available to patients in the US in a matter of months.
“With a gallon of scorpion venom costing upwards of $39 million, expanding our own cultivation reservation in order to meet our internal demand for the peptides used in Escozine only made further sense,” said Medolife CEO Dr. Arthur Mikaelian. “We have one of the largest scorpion reservations in the world and this expansion only further solidifies that position. As we await our pending regulatory approvals, which we expect in short order starting within the DR, we must prepare to meet the immediate demand the approvals will render by increasing our scorpion cultivation efforts. While we plan to focus first on the Rhopalurus princeps, which is one of several types of Blue Scorpions, the expansion will also allow us to add other scorpions such as Rhopalurus abudi, whose venom has seen promising results in treating various cancers. Our next step of adding a lab facility to the location is imminent, and we will be able to fully integrate our supply chain of Escozine® and further position Medolife as an integrated global pharmaceutical and nutraceutical company.”
Medolife is dedicated to enhancing the efficiency and capacity of the reservation and adding more key personnel who are experts in scorpion reproduction and habitat. The process of extraction of the peptides does not harm the scorpions and can be repeated every 23 days, creating an ongoing value chain of peptide production. The increase in the size of the reservation allows for a reduction in the scorpion density per population and the addition of a lab in the future will provide insurance against unanticipated weather and environmental catastrophes.
https://finance.yahoo.com/news/medolife-rx-furthers-expansion-scorpion-130000236.html?.tsrc=rss
April 08, 2021
Medolife Rx Announces Positive Pre-Clinical Results Showing Up to 95 Percent Cancer Cell Apoptosis with Introduction of Lead Cancer Drug Candidate
Medolife Rx, Inc. ("Medolife"), a global integrated bioceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. (OTC PINK: QNTA), announced today pre-clinical study results conducted at one of the leading cancer research centers in the United States showing that the Company’s lead drug candidate Escozine® caused up to 95 percent Specific Induced Apoptosis (SIA) in various types of Leukemia cancer cells. Such a result is significant not only to the Company’s ongoing clinical research, but could have tremendous effects on cancer treatments worldwide.
The study was broken into two objectives:
to evaluate the effect of Escozine® at four different concentration levels on the induction of apoptosis in five cancer cell lines: K-562: Human Chronic Myeloid Leukemia (CML); MEC-1: Human Chronic B Cell Leukemia; NAMALWA: Human Burkitt Lymphoma; RAJI: Human Burkitt Lymphoma, TP53 Wild Type; RAMOS: Human Burkitt Lymphoma, TP53 Mutated
to evaluate the effect of Escozine® at four different concentration levels on the induction of apoptosis in four Chronic Lymphocytic Leukemia (CLL) patients, two at high-risk and two at low-risk levels
The result of the first objective was that cell death was observed in all cell lines when treated with Escozine® after 48 hours of incubation. The effect on cell death was dependent on the concentration level of Escozine®, with insignificant cell death being observed in concentration levels from 10-30 percent, a variation of cell death between 5-40 percent at a 50 percent concentration of Escozine®, and a greater than 95 percent cell death in all cell lines when Escozine® was included at 100 percent concentration, with the exception of RAMOS, which showed an approximate 50 percent cell death rate.
In the second part of the study, cells were taken from four CLL human patients, two High Risk (HR) and two Low Risk (LR). The cells were introduced to Escozine® at varying concentrations, and the results showed that both HR patients reported minimal effects at concentrations of 10 percent and 30 percent of Escozine®; however, at concentrations of 50 percent, cell death occurred in approximately 50 percent of cells, and at 100 percent concentration levels, over 95 percent cell death was observed. In LR patients, similar results were observed with higher concentrations of Escozine® at 50 percent and 100 percent inclusion where high levels of cell death were observed. The results were consistent with the cell line portion of the study, confirming that Escozine at higher concentrations can cause SIA, or cell death, in greater than 95 percent of cancer cells.
“These results not only met our expectations, but exceeded them,” said Medolife CEO Dr. Arthur Mikaelian. “This study was conducted at one of the leading academic cancer research institutes in the United States under some of the most stringent guidelines. While we knew that Escozine had cancer fighting therapeutic benefits, to see over 95 percent of cancer cells killed when introduced to the drug was truly groundbreaking. Cancer is one of the leading causes of death worldwide and finding an effective therapeutic is known as the holy grail of medicine. While we still have research to conduct in order to prove this drug is an effective treatment for cancer, results like these from such a credible institution will pave the way for this further exploration.”
https://finance.yahoo.com/news/medolife-rx-announces-positive-pre-123000065.html?.tsrc=rss
April 13, 2021
Medolife Rx Submits Final Data Set to FDA for IND Filing on Lead Drug Candidate
Medolife Rx, Inc. ("Medolife"), a global integrated bioceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. (OTC PINK: QNTA), announced today that it has filed its final set of data requested by the US Food and Drug Administration (FDA) for its Pre-Investigational New Drug (PIND #150335) filing on its lead drug candidate Escozine® as a COVID-19 therapeutic. Along with the submission of a batch of Escozine® previously announced specifically produced for the FDA, the Company believes that this will be the last submission necessary in order to receive IND designation from the regulatory body in the United States.
Previous clinical data was submitted to the FDA including preliminary results of the safety study, which has now been expanded upon. This data, as well as the batch of Escozine® that was produced specifically for the FDA, has now been submitted. After the review of the data and barring any further inquiries or requests, the FDA will designate IND status for Escozine®, essentially allowing the drug to be distributed in the US. After such designation, the Company will pursue other clinical applications of Escozine®, including as a potential cancer therapeutic where the Company has already released positive clinical results.
“The FDA-approved therapeutic drug market is the gold standard globally and should we receive IND designation from the FDA, it would catapult our other research across the world,” said Medolife CEO Dr. Arthur Mikaelian. “Submission to the FDA is never easy, but we are generating such positive clinical trial results that we are confident the regulatory body will take notice. They have been reviewing our submission for some time, requesting various other information that we have now submitted. I believe this could be the last request ahead of approval, which would be tremendous not only for our Company, but for patients who are in need of a solution where one does not currently exist. An approval from the FDA would also propel interest from the scientific community on the potential therapeutic benefits of the natural peptides we are studying, including investment and partnership interest.”
https://finance.yahoo.com/news/medolife-rx-submits-final-data-123000200.html?.tsrc=rss
ENZC is well funded to support their on-going operations with probable sources of income coming down the pipeline.
Their collaboration with INTEL is not about funding it is about potential, being ahead of the curve, leading the charge and exposure.
If ENZC is to ever get major funding it will most likely come from big pharma or a very ambitious VC.
It is good exposure for ENZC and Intel as well.
If ENZC had received funding they would had to report it to their stockholders.
ENZC don't need hope they have the SCIENCE!!!
? Mandy Hale
In the United States, it takes an average of 12 years for an experimental drug to travel from the laboratory to your medicine cabinet. That is, if it makes it. Only 5 in 5,000 drugs that enter preclinical testing progress to human testing. One of these 5 drugs that are tested in people is approved.
Does a Drug Approval Mean Higher Stock Price?
Answering the question, "Does a Drug Approval Mean a Higher Stock Price?" is fairly straight forward, but there are some caveats that investors need to be aware of. The simple answer is yes, in most cases a new drug approval can lead to a higher share price for the company on the receiving end of that approval. However, each company and approval need to be considered individually so investors can avoid drug approval disappointment.
[b[color=blue]]What Is The Approved Drug?[/color]
The word "blockbuster" is often used in association with new drug approvals and history has shown that is exactly what a company needs to have approved to ensure its shares skyrocket post-approval. Examples of potential blockbuster drugs would include, but are not limited to, treatments for cancer, diabetes and sexually transmitted diseases. Another way of looking at this situation is this. A pharmaceutical company has just received approval to sell a new treatment for common allergy symptoms. While that drug may eventually prove to be an important part of the company's revenue stream, it is used to treat a mundane condition and unlikely to really jolt the company's shares.
What Company Is Getting The Approval?
In some cases, the company on the receiving end of a new drug approval is almost as important as what drug is being approved. In this case, before approval, investors should evaluate the potential impact of the new drug on the company's top and bottom lines. For example, there have been examples of small biotechnology companies that, because of funding constraints, only work on one or two major treatments at a given time. Financial markets are aware of this and when those companies land drug approvals, the shares usually surge. On the other hand, an established, large-cap pharmaceuticals company can land a new drug approval, but if that drug is only expected to account for a small percentage of profit and revenue, the approval is unlikely to do much for the share price.
Who Is Doing The Approving?
When it comes to regulatory bodies that affect a drug company's share price, none exceed the importance of the U.S. Food and Drug Administration. Arguably, the only entity that comes remotely close is the European Union's equivalent of the FDA. That is to say a company may get its new blockbuster drug approved in Brazil, but that alone is unlikely to have a significant impact on the shares. The company's investors will want to see the drug approved in the U.S. or Europe, preferably both, for maximum reward on their investment.
Consider Costs
Many new blockbuster drugs, particularly those that treat cancer or genetic diseases, are expensive. Related to the issue of pure cost is whether or not health insurance providers will help their patients make up the difference in purchasing expensive new drugs. Bottom line: If a new drug is ultra-expensive to the point that it cannot be accessed by patients and insurance providers are reluctant to absorb the cost, the manufacturer is not going to sell much of that drug and that is not good for the share price.
****Escozine is not expensive as compared to other drugs so once it is approved and it becomes a viable alternative or additional treatment the sky is the limit.****
https://finance.zacks.com/drug-approval-mean-higher-stock-price-8390.html
13-Point Checklist for Buying a Biotech Stock
Here are encouraging signs to look for, and less-than-obvious pitfalls to avoid, when buying biotech stocks.
Gaining an exclusive license to sell a life-changing -- sometimes lifesaving -- drug creates an opportunity even the greenest investor can understand. T
If you're looking for advice to make quick gains from trading around market catalysts, I'm afraid this is the wrong place. However, if you're considering buying biotech stocks as long-term investments, this checklist will help you identify encouraging signs, while avoiding common mistakes.
1. Check if the company is out of the clinical stage
A majority of the biotech industry's smaller members are in the clinical stage. In other words, they don't have a product to sell yet, but they're testing potential drugs in humans. They are extremely risky, and volatile. Less-than-positive results from an important clinical trial can result in heavy losses that might be temporary, but still present a great deal of risk.
For example, bluebird bio may have potential cures for some devastating diseases, but its stock was beaten up after posting less-than-positive data from a very small clinical trial last year. Celldex Therapeutics shares were hammered when one of several promising candidates failed a clinical trial, even though its other candidates look very promising.
While I think these two stocks will turn around and provide fantastic gains in the long run, their future is uncertain. Human physiology can be surprisingly uncooperative and leave you with long-term losses. So, if you're interested in sleeping well at night, it may be best to stick to commercial-stage companies with proven products on the market.
2. Remember that commercial-stage companies are still risky
The vast majority of commercial-stage biotech companies (i.e. those with one or more approved products) are "growth" stocks. That's finance jargon for shoveling every penny of profit, sometimes more, back into their operations. This isn't necessarily bad, but a few wrong turns from management, and you could end up stuck with long-term losses.
For example, Vertex Pharmaceuticals (NASDAQ:VRTX) recently announced a record-breaking first quarter, reporting $398.1 million in revenue. About $255.8 spent on R&D was its single largest expense, but the company still produced a net loss of over $41 million in the first quarter.
Vertex sells the only approved drugs that treat the root cause of cystic fibrosis, and this year's top line is expected to be over 70% higher than last year's. At a recent price of about 12 times this year's sales estimates, the slightest indication Vertex can't continue to expand sales, and eventually profits, at a phenomenal rate in the years ahead could lead to a stock market hammering.
Partners AbbVie and Galapagos are hard at work to introduce some competition. The odds are long, but if this team, or any others, pressure Vertex's sales, the stock could remain depressed.
3. When buying biotech stocks, check your risk tolerance
An investor in his or her twenties without dependents can afford to take risks most fifty-somethings can't. Unfortunately appetites for risk often outweigh tolerances. I've seen too many investors lose more than they can afford to on biotech stocks; please don't become another.
The good news is that a handful of biotechs generate cash flows that outweigh their R&D reinvestment opportunities, which is a good indicator of a biotech's stability. Companies like Amgen and Gilead Sciences are so well established that they're paying dividends and buying back shares. Even if your risk tolerance is practically zero -- a category I fit in -- even Johnson & Johnson provides some exposure to the biotech industry.
Again, nothing is certain. However, your chances of suffering long-term losses with a company generating plenty of money and returning profits to shareholders are much lower than with any of the previously mentioned stocks.
Now that you know the difference between clinical- and commercial-stage biotechs, and the inherent risks that come with them, let's dive into some less obvious hazards.
4. Check whether your biotech stock has all its eggs in one basket
Drug development expenses rise exponentially as clinical-stage drugs get closer to the FDA approval finish line. For this reason, it's not unusual for a clinical-stage company to devote a majority of its limited resources to the candidate with the best chance of crossing that line.
What you want to avoid are companies without any backup programs. For example, Puma Biotechnology (NASDAQ:PBYI) is entirely devoted to development of neratinib for treatment of certain forms of breast cancer.
Over the past couple years the market has become less optimistic about that drug's future. When the FDA requested a change in the statistical analysis in March, the stock was subsequently hammered, again. Puma Biotechnology still plans to file an application for a limited breast cancer indication sometime this year. If it doesn't earn an approval, and impress oncologists, shareholders might never recover from the crushing losses.
5. Check for interest from bigger players
Unlike Puma Biotechnology, Ionis Pharmaceuticals (NASDAQ:IONS) discovers new drug candidates internally, and lots of them. Discovery is relatively easy, but moving drugs through clinical stages requires more resources than most biotechs have available.
Luckily, plenty of bigger companies are willing to fund development of Ionis' candidates for share of potential sales. Last the biotech racked up $283 million in total revenue without making any sales of its own It has so many collaborations with bigger drugmakers that I couldn't list them here without breaking the Internet.
In the years ahead, if its late-stage drugs begin earning sales, and the royalty checks start rolling in, Ionis will probably quit out-licensing the drugs it discovers and begin developing them with its own resources. This could lead to big gains for patient investors.
We've seen this story before: Over 20 years ago, Biogen let Roche help it develop what eventually became Rituxan and Gazyva. Last year Biogen's share of Rituxan's and Gazyva's operating profits totaled $1.3 billion, and Biogen has effectively used those cash flows to develop its own drugs to great success. Biogen shareholders who held on since the beginning of that partnership have enjoyed astronomical gains, beating the S&P 500 by miles.
6. Avoid clinical-stage biotechs with big pipelines and no partners
Now that you've seen what can happen in the long run when biotechs which are discovering new drug candidates form partnerships, let's look at what happens when they don't.
Anavex Life Sciences (NASDAQ:AVXL) has a burgeoning pre-clinical pipeline. It's also in preparation for a phase 2/3 trial with 2-73, its lead candidate for treatment of Alzheimer's disease. If 2-73 succeeds, it could become one of the best-selling drugs of all time, but Anavex investors have watched their share of any profits the company might generate dwindle: Without a partner, the company must fund its program with equity. Adjusting for the 4-for-1 share consolidation ahead of its uplisting to the Nasdaq exchange last October, the number of outstanding shares has risen 373% over the past two years, from 9.57 million at the end of March 2014 to 35.70 million at the end of this March.
Suppose you bought four shares of Anavex two years ago. Also imagine a partner swoops in today and funds development of its pipeline, and the company stops diluting shares from this point forward. If it produced a $9.57 million profit at some point in the future instead of reporting earnings of $1 per share, Anavex would report just $0.27 per share.
The company is authorized to sell a lot more stock, and investors who have been hanging on over the past several years will probably see their share of any potential profits dwindle much further.
7. Check the ratio of upfront cash to biobucks
The term "biobucks" is industry jargon for potential payouts if drugs pass regulatory and commercial milestones. If you're thinking of buying a biotech stock because the company just announced a billion-dollar deal, look at how much the larger company offered upfront. The deal may entail delayed payments that are tied to developmental or commercial milestones in addition to an upfront payment. Generally a bigger initial payment signifies confidence, or even multiple bidders.
Not all partnership and licensing deals are the same, and the devil's in the details. For example, blue-chip biotech Celgene's 10% equity stake in Juno Therapeutics, combined with $150 million upfront, signifies a strong belief in Juno's potential.
A $10 million upfront payment to a new biotech with an interesting drug development platform to discover multiple new drug candidates, each worth potentially hundreds of millions in biobucks, is hardly worth a press release, but it usually results in one -- which brings us to the next point on our checklist.
8. Check the ratio of press releases to clinical trials
Touting minor developments isn't necessarily bad, but it should raise yellow flags when you think about buying biotech stocks. This could be the result of an over-caffeinated employee in the media relations office -- or it could be a sign the company is building a house of cards.
A quick way to decide if a biotech company is actually doing something worthwhile is to search the ClinicalTrials.gov database for the company's name. If it's sponsoring plenty of active trials, those press releases might indeed be worthwhile.
9. Check press releases against info in the ClinicalTrials.gov database
All trials have primary and secondary endpoints. Without a doubt, the primary endpoint is the most important one and the one that reflects the most important question being asked in a trial. Secondary endpoints are relevant, but to a much lesser extent. Sometimes a biotech will play up success related to a bunch of secondary endpoints, while burying the fact it didn't do so great at meeting the trial's main goal.
If the results you read in press releases don't jive with the official description of the trial, it could signify trouble.
10. Be encouraged by control groups in early stage trials
A control group is science-geek jargon for the people getting either the placebo or the current standard of care for their disease, rather than the experimental drug. Be extremely wary of biotechs touting positive efficacy results from trials without control groups.
Phase 1 and phase 2 trials don't require control groups because they're testing for safety and determining an effective dosage, respectively. However, be encouraged when a biotech is willing to include a control group in early trials, because it's a big pain in the rear.
In the case of Inotek's recent phase 2 dose escalation trial with trabodenoson for treatment of glaucoma, it went through the trouble of hiring an outside group of professionals to create a placebo, and keep it a secret. If trabodenoson drops don't sting, or have any smell, or color, the placebo could simply be saline. More often than not, creating an acceptable placebo can delay trials for months, and at no small expense.
However, Inotek made the extra effort, and it paid off: One of the higher doses of trabodenoson was significantly more effective than placebo. Now the company can fund a bigger, far more expensive phase 3 trial with confidence, and its shareholders can rest easier.
Conversely, be wary if a company is willing to run a long trial, especially a phase 2, without a control group. It could signify management's lack of confidence in its candidate.
11. Check for statistical significance
Beginning biotech investors and a shocking number of scientists tend to forget that statistics are an attempt to predict what will happen in the real world, using a limited amount of available data. With respect to a drug's efficacy against a placebo, or the existing standard treatment, it's all about the p-value.
While a p-value of 0.05 is generally considered significant, it's important to understand this figure in the context of efficacy results. A p-value of exactly 0.05 means that the odds that chance accounted for the results are just 5 out of 100. Clearly, the lower the p-value, the better.
Recall our earlier definition of primary versus secondary endpoints. If you see a company touting a secondary efficacy outcome result with a p-value of 0.048, get nervous. When you see primary efficacy outcome-related p-values with several zeros on the right of the decimal point, get excited.
12. Remember FDA meetings and letters are not subject to full disclosure
The divisions of the FDA that deal with biotechs do not behave like any government agencies I'm familiar with. When consulting with companies in preparation for trials intended to support drug applications, the FDA is generally clear about what it wants to see. It's not uncommon for biotechs to ignore the Agency's recommendations in attempts to save time and money.
New drug applications are rarely rejected outright; instead, biotechs usually receive "complete response" letters, or CRL. They basically contain a list of things the FDA wanted, but didn't get. CRLs aren't necessarily a new drug's death sentence, but they usually are.
Most importantly, their contents are confidential. The biotech might disclose minor parts, such as: "There were concerns about the manufacturing process. We've already sorted it out and we'll resubmit in the first half of next year."
That could be the extent of the letter's contents. Generally, it's what biotechs don't disclose that leave you with long-term losses.
13. Check for pooled data analyses
After a trial fails to meet its primary endpoint, biotechs large and small are often unwilling to admit defeat. One of the most common last ditch efforts to save a program is to combine or "pool" data from separate trials and find a group that benefited. While this may be a reason to run another trial specific to the group that benefited, consider attempts to submit new drug applications based on pooled data analyses failures waiting to happen.
A stunning example of such behavior came from PTC Therapeutics (NASDAQ:PTCT). Last October the company announced its lead candidate, ataluren, for treatment of Duchenne muscular dystrophy, failed to meet its primary endpoint, improvement in distance patients were able to walk in six minutes after 48 weeks.
When PTC therapeutics announced the failure last October, it quickly pointed to promising data from a "pre-specified population" in the phase 3 study, pooled with patients from an earlier phase 2b trial. Although the clinical trial protocol screened specifically for patients able to walk 150 or more meters at the beginning of treatment, PTC Therapeutics noted that a pooled group of patients that began the phase 2b and phase 3 study able to walk between 300 meters and 400 meters in the six-minute test showed a statistically significant improvement after 48 weeks.
If the company had met with the FDA about running another registrational trial specific to this group of patients, that would have been a setback, but perhaps worth the effort. Instead PTC Therapeutics submitted an application for approval of the drug this January on the pooled data alone, and the FDA refused to file it in late February.
Anyone familiar with the FDA's stance on similar post hoc analyses would have known the application was doomed, but it took Wall Street by surprise:
This won't be the last time a company tries this tactic, but hopefully the next time something like this happens, you'll be ready.
If you've checked the biotech stocks you intend to buy against all these points, congratulations! You're no longer a rookie. In fact, you'll probably outperform most Wall Street biotech fund managers.
https://www.fool.com/investing/general/13-point-checklist-for-buying-a-biotech-stock.aspx
13-Point Checklist for Buying a Biotech Stock
Here are encouraging signs to look for, and less-than-obvious pitfalls to avoid, when buying biotech stocks.
Gaining an exclusive license to sell a life-changing -- sometimes lifesaving -- drug creates an opportunity even the greenest investor can understand. T
If you're looking for advice to make quick gains from trading around market catalysts, I'm afraid this is the wrong place. However, if you're considering buying biotech stocks as long-term investments, this checklist will help you identify encouraging signs, while avoiding common mistakes.
1. Check if the company is out of the clinical stage
A majority of the biotech industry's smaller members are in the clinical stage. In other words, they don't have a product to sell yet, but they're testing potential drugs in humans. They are extremely risky, and volatile. Less-than-positive results from an important clinical trial can result in heavy losses that might be temporary, but still present a great deal of risk.
For example, bluebird bio may have potential cures for some devastating diseases, but its stock was beaten up after posting less-than-positive data from a very small clinical trial last year. Celldex Therapeutics shares were hammered when one of several promising candidates failed a clinical trial, even though its other candidates look very promising.
While I think these two stocks will turn around and provide fantastic gains in the long run, their future is uncertain. Human physiology can be surprisingly uncooperative and leave you with long-term losses. So, if you're interested in sleeping well at night, it may be best to stick to commercial-stage companies with proven products on the market.
2. Remember that commercial-stage companies are still risky
The vast majority of commercial-stage biotech companies (i.e. those with one or more approved products) are "growth" stocks. That's finance jargon for shoveling every penny of profit, sometimes more, back into their operations. This isn't necessarily bad, but a few wrong turns from management, and you could end up stuck with long-term losses.
For example, Vertex Pharmaceuticals (NASDAQ:VRTX) recently announced a record-breaking first quarter, reporting $398.1 million in revenue. About $255.8 spent on R&D was its single largest expense, but the company still produced a net loss of over $41 million in the first quarter.
Vertex sells the only approved drugs that treat the root cause of cystic fibrosis, and this year's top line is expected to be over 70% higher than last year's. At a recent price of about 12 times this year's sales estimates, the slightest indication Vertex can't continue to expand sales, and eventually profits, at a phenomenal rate in the years ahead could lead to a stock market hammering.
Partners AbbVie and Galapagos are hard at work to introduce some competition. The odds are long, but if this team, or any others, pressure Vertex's sales, the stock could remain depressed.
3. When buying biotech stocks, check your risk tolerance
An investor in his or her twenties without dependents can afford to take risks most fifty-somethings can't. Unfortunately appetites for risk often outweigh tolerances. I've seen too many investors lose more than they can afford to on biotech stocks; please don't become another.
The good news is that a handful of biotechs generate cash flows that outweigh their R&D reinvestment opportunities, which is a good indicator of a biotech's stability. Companies like Amgen and Gilead Sciences are so well established that they're paying dividends and buying back shares. Even if your risk tolerance is practically zero -- a category I fit in -- even Johnson & Johnson provides some exposure to the biotech industry.
Again, nothing is certain. However, your chances of suffering long-term losses with a company generating plenty of money and returning profits to shareholders are much lower than with any of the previously mentioned stocks.
Now that you know the difference between clinical- and commercial-stage biotechs, and the inherent risks that come with them, let's dive into some less obvious hazards.
4. Check whether your biotech stock has all its eggs in one basket
Drug development expenses rise exponentially as clinical-stage drugs get closer to the FDA approval finish line. For this reason, it's not unusual for a clinical-stage company to devote a majority of its limited resources to the candidate with the best chance of crossing that line.
What you want to avoid are companies without any backup programs. For example, Puma Biotechnology (NASDAQ:PBYI) is entirely devoted to development of neratinib for treatment of certain forms of breast cancer.
Over the past couple years the market has become less optimistic about that drug's future. When the FDA requested a change in the statistical analysis in March, the stock was subsequently hammered, again. Puma Biotechnology still plans to file an application for a limited breast cancer indication sometime this year. If it doesn't earn an approval, and impress oncologists, shareholders might never recover from the crushing losses.
5. Check for interest from bigger players
Unlike Puma Biotechnology, Ionis Pharmaceuticals (NASDAQ:IONS) discovers new drug candidates internally, and lots of them. Discovery is relatively easy, but moving drugs through clinical stages requires more resources than most biotechs have available.
Luckily, plenty of bigger companies are willing to fund development of Ionis' candidates for share of potential sales. Last the biotech racked up $283 million in total revenue without making any sales of its own It has so many collaborations with bigger drugmakers that I couldn't list them here without breaking the Internet.
In the years ahead, if its late-stage drugs begin earning sales, and the royalty checks start rolling in, Ionis will probably quit out-licensing the drugs it discovers and begin developing them with its own resources. This could lead to big gains for patient investors.
We've seen this story before: Over 20 years ago, Biogen let Roche help it develop what eventually became Rituxan and Gazyva. Last year Biogen's share of Rituxan's and Gazyva's operating profits totaled $1.3 billion, and Biogen has effectively used those cash flows to develop its own drugs to great success. Biogen shareholders who held on since the beginning of that partnership have enjoyed astronomical gains, beating the S&P 500 by miles.
6. Avoid clinical-stage biotechs with big pipelines and no partners
Now that you've seen what can happen in the long run when biotechs which are discovering new drug candidates form partnerships, let's look at what happens when they don't.
Anavex Life Sciences (NASDAQ:AVXL) has a burgeoning pre-clinical pipeline. It's also in preparation for a phase 2/3 trial with 2-73, its lead candidate for treatment of Alzheimer's disease. If 2-73 succeeds, it could become one of the best-selling drugs of all time, but Anavex investors have watched their share of any profits the company might generate dwindle: Without a partner, the company must fund its program with equity. Adjusting for the 4-for-1 share consolidation ahead of its uplisting to the Nasdaq exchange last October, the number of outstanding shares has risen 373% over the past two years, from 9.57 million at the end of March 2014 to 35.70 million at the end of this March.
Suppose you bought four shares of Anavex two years ago. Also imagine a partner swoops in today and funds development of its pipeline, and the company stops diluting shares from this point forward. If it produced a $9.57 million profit at some point in the future instead of reporting earnings of $1 per share, Anavex would report just $0.27 per share.
The company is authorized to sell a lot more stock, and investors who have been hanging on over the past several years will probably see their share of any potential profits dwindle much further.
7. Check the ratio of upfront cash to biobucks
The term "biobucks" is industry jargon for potential payouts if drugs pass regulatory and commercial milestones. If you're thinking of buying a biotech stock because the company just announced a billion-dollar deal, look at how much the larger company offered upfront. The deal may entail delayed payments that are tied to developmental or commercial milestones in addition to an upfront payment. Generally a bigger initial payment signifies confidence, or even multiple bidders.
Not all partnership and licensing deals are the same, and the devil's in the details. For example, blue-chip biotech Celgene's 10% equity stake in Juno Therapeutics, combined with $150 million upfront, signifies a strong belief in Juno's potential.
A $10 million upfront payment to a new biotech with an interesting drug development platform to discover multiple new drug candidates, each worth potentially hundreds of millions in biobucks, is hardly worth a press release, but it usually results in one -- which brings us to the next point on our checklist.
8. Check the ratio of press releases to clinical trials
Touting minor developments isn't necessarily bad, but it should raise yellow flags when you think about buying biotech stocks. This could be the result of an over-caffeinated employee in the media relations office -- or it could be a sign the company is building a house of cards.
A quick way to decide if a biotech company is actually doing something worthwhile is to search the ClinicalTrials.gov database for the company's name. If it's sponsoring plenty of active trials, those press releases might indeed be worthwhile.
9. Check press releases against info in the ClinicalTrials.gov database
All trials have primary and secondary endpoints. Without a doubt, the primary endpoint is the most important one and the one that reflects the most important question being asked in a trial. Secondary endpoints are relevant, but to a much lesser extent. Sometimes a biotech will play up success related to a bunch of secondary endpoints, while burying the fact it didn't do so great at meeting the trial's main goal.
If the results you read in press releases don't jive with the official description of the trial, it could signify trouble.
10. Be encouraged by control groups in early stage trials
A control group is science-geek jargon for the people getting either the placebo or the current standard of care for their disease, rather than the experimental drug. Be extremely wary of biotechs touting positive efficacy results from trials without control groups.
Phase 1 and phase 2 trials don't require control groups because they're testing for safety and determining an effective dosage, respectively. However, be encouraged when a biotech is willing to include a control group in early trials, because it's a big pain in the rear.
In the case of Inotek's recent phase 2 dose escalation trial with trabodenoson for treatment of glaucoma, it went through the trouble of hiring an outside group of professionals to create a placebo, and keep it a secret. If trabodenoson drops don't sting, or have any smell, or color, the placebo could simply be saline. More often than not, creating an acceptable placebo can delay trials for months, and at no small expense.
However, Inotek made the extra effort, and it paid off: One of the higher doses of trabodenoson was significantly more effective than placebo. Now the company can fund a bigger, far more expensive phase 3 trial with confidence, and its shareholders can rest easier.
Conversely, be wary if a company is willing to run a long trial, especially a phase 2, without a control group. It could signify management's lack of confidence in its candidate.
11. Check for statistical significance
Beginning biotech investors and a shocking number of scientists tend to forget that statistics are an attempt to predict what will happen in the real world, using a limited amount of available data. With respect to a drug's efficacy against a placebo, or the existing standard treatment, it's all about the p-value.
While a p-value of 0.05 is generally considered significant, it's important to understand this figure in the context of efficacy results. A p-value of exactly 0.05 means that the odds that chance accounted for the results are just 5 out of 100. Clearly, the lower the p-value, the better.
Recall our earlier definition of primary versus secondary endpoints. If you see a company touting a secondary efficacy outcome result with a p-value of 0.048, get nervous. When you see primary efficacy outcome-related p-values with several zeros on the right of the decimal point, get excited.
12. Remember FDA meetings and letters are not subject to full disclosure
The divisions of the FDA that deal with biotechs do not behave like any government agencies I'm familiar with. When consulting with companies in preparation for trials intended to support drug applications, the FDA is generally clear about what it wants to see. It's not uncommon for biotechs to ignore the Agency's recommendations in attempts to save time and money.
New drug applications are rarely rejected outright; instead, biotechs usually receive "complete response" letters, or CRL. They basically contain a list of things the FDA wanted, but didn't get. CRLs aren't necessarily a new drug's death sentence, but they usually are.
Most importantly, their contents are confidential. The biotech might disclose minor parts, such as: "There were concerns about the manufacturing process. We've already sorted it out and we'll resubmit in the first half of next year."
That could be the extent of the letter's contents. Generally, it's what biotechs don't disclose that leave you with long-term losses.
13. Check for pooled data analyses
After a trial fails to meet its primary endpoint, biotechs large and small are often unwilling to admit defeat. One of the most common last ditch efforts to save a program is to combine or "pool" data from separate trials and find a group that benefited. While this may be a reason to run another trial specific to the group that benefited, consider attempts to submit new drug applications based on pooled data analyses failures waiting to happen.
A stunning example of such behavior came from PTC Therapeutics (NASDAQ:PTCT). Last October the company announced its lead candidate, ataluren, for treatment of Duchenne muscular dystrophy, failed to meet its primary endpoint, improvement in distance patients were able to walk in six minutes after 48 weeks.
When PTC therapeutics announced the failure last October, it quickly pointed to promising data from a "pre-specified population" in the phase 3 study, pooled with patients from an earlier phase 2b trial. Although the clinical trial protocol screened specifically for patients able to walk 150 or more meters at the beginning of treatment, PTC Therapeutics noted that a pooled group of patients that began the phase 2b and phase 3 study able to walk between 300 meters and 400 meters in the six-minute test showed a statistically significant improvement after 48 weeks.
If the company had met with the FDA about running another registrational trial specific to this group of patients, that would have been a setback, but perhaps worth the effort. Instead PTC Therapeutics submitted an application for approval of the drug this January on the pooled data alone, and the FDA refused to file it in late February.
Anyone familiar with the FDA's stance on similar post hoc analyses would have known the application was doomed, but it took Wall Street by surprise:
This won't be the last time a company tries this tactic, but hopefully the next time something like this happens, you'll be ready.
If you've checked the biotech stocks you intend to buy against all these points, congratulations! You're no longer a rookie. In fact, you'll probably outperform most Wall Street biotech fund managers.
In the United States, it takes an average of 12 years for an experimental drug to travel from the laboratory to your medicine cabinet. That is, if it makes it. Only 5 in 5,000 drugs that enter preclinical testing progress to human testing. One of these 5 drugs that are tested in people is approved.
Does a Drug Approval Mean Higher Stock Price?
Answering the question, "Does a Drug Approval Mean a Higher Stock Price?" is fairly straight forward, but there are some caveats that investors need to be aware of. The simple answer is yes, in most cases a new drug approval can lead to a higher share price for the company on the receiving end of that approval. However, each company and approval need to be considered individually so investors can avoid drug approval disappointment.
What Is The Approved Drug?
The word "blockbuster" is often used in association with new drug approvals and history has shown that is exactly what a company needs to have approved to ensure its shares skyrocket post-approval. Examples of potential blockbuster drugs would include, but are not limited to, treatments for cancer, diabetes and sexually transmitted diseases. Another way of looking at this situation is this. A pharmaceutical company has just received approval to sell a new treatment for common allergy symptoms. While that drug may eventually prove to be an important part of the company's revenue stream, it is used to treat a mundane condition and unlikely to really jolt the company's shares.
What Company Is Getting The Approval?
In some cases, the company on the receiving end of a new drug approval is almost as important as what drug is being approved. In this case, before approval, investors should evaluate the potential impact of the new drug on the company's top and bottom lines. For example, there have been examples of small biotechnology companies that, because of funding constraints, only work on one or two major treatments at a given time. Financial markets are aware of this and when those companies land drug approvals, the shares usually surge. On the other hand, an established, large-cap pharmaceuticals company can land a new drug approval, but if that drug is only expected to account for a small percentage of profit and revenue, the approval is unlikely to do much for the share price.
Who Is Doing The Approving?
When it comes to regulatory bodies that affect a drug company's share price, none exceed the importance of the U.S. Food and Drug Administration. Arguably, the only entity that comes remotely close is the European Union's equivalent of the FDA. That is to say a company may get its new blockbuster drug approved in Brazil, but that alone is unlikely to have a significant impact on the shares. The company's investors will want to see the drug approved in the U.S. or Europe, preferably both, for maximum reward on their investment.
Consider Costs
Many new blockbuster drugs, particularly those that treat cancer or genetic diseases, are expensive. Related to the issue of pure cost is whether or not health insurance providers will help their patients make up the difference in purchasing expensive new drugs. Bottom line: If a new drug is ultra-expensive to the point that it cannot be accessed by patients and insurance providers are reluctant to absorb the cost, the manufacturer is not going to sell much of that drug and that is not good for the share price.
****Escozine is not expensive as compared to other drugs so once it is approved and it becomes a viable alternative or additional treatment the sky is the limit.****
https://finance.zacks.com/drug-approval-mean-higher-stock-price-8390.html
Today news is just a sliver of what is going on with Medolife.
Medolife has been researching Escozine® as a potential treatment for COVID-19 in clinical research programs in both the United States and the DR. The Company has completed numerous safety and efficacy studies on the drug, and filed a final data set with the US Food and Drug Administration (FDA) as it relates to an Investigational New Drug (IND) filing on Escozine®. The Company is in the process of registration for medical ethics committee approval to conduct double-blind placebo human studies on Escozine®, which would mark a substantial step forward in Escozine’s path toward worldwide registration and adoption.
Once Escozine is approved for use for Covid-19 therapeutic, the domino effect will come into play.
There are many potential uses for Escozine and some are in research and development for future FDA submission and approval.
Research and Development
Natural Products in Development:
Escozine™ Spray Solution
Escozine™ Enema Solution
Medical Grade Products in Development for FDA Approval:
Escozine GNP-1™
ESCOZINE GNP-1™ is in research and development as an advanced anti-cancer drug. Polarized gold nanoparticles combined with a novel peptide extracted from the Caribbean Blue Scorpion venom, potentiates the bioactive compound and increases the effectiveness of the natural compound up to synthetic drug strength by efficiency. The result is a new category of powerful medications without considerable side effects.
Medolife™ is presently preparing to apply to the FDA (Food and Drug Administration) for clinical trials in the United States for ESCOZINE GNP-1™.
Patch – preparing to apply for FDA approval
Four types of Escozine patch are in the research and development stage and these will provide an easy, targeted and effective delivery solution for the product. The enhanced transdermal technology system will allow Escozine’s small molecule peptide to pass through skin’s barrier layer of stratum corneum directly to the target location. The patches that are being developed are:
Breast Patch
Prostate Patch
Skin Patch
Immune Enhancer Patch
Injectable – preparing to apply for FDA approval
Medolife expects to have promising results with an injectable version which is currently in research and development. The product will be directly injected into the tumor by normal injectable methods or by Electrophoresis.
In many cases, doctors cannot perform necessary surgery or use chemotherapy because of tumor location or the patient’s health condition.
Escozine Injectable can become a useful tool for doctors and surgeons.
I.V (Intravenous) – preparing to apply for FDA approval
For those who require a more monitored treatment process, the intravenous version will provide an effective solution for doctors. This version of the product is in research and development in cooperation with Synthesis Laboratories.
Quanta for 2021 will be undergoing a name change to be announced shortly as well as Quanta is in the process of expanding its product line from 4 SKUs to 38 by summer. We will also be introducing all new branding with new color schemes, new packaging, and exciting celebrity endorsements for the pain relief products and a newly introduced beauty product line.
Quanta will also be working on a men’s cosmetic line in conjunction with one of the celebrity endorsements planned for late 2021. The company has hired an advertising agency to help with the rollout of the new branding expected second quarter 2021. This will work in conjunction with a major push the company is on the path of with some major big box retail chains.
Quanta Basics
Quanta is a cutting-edge technology platform whose patented, proprietary technology harnesses advances in quantum biology to increase the potency of active ingredients. Currently, Quanta supports product formulations in pain management, anti-inflammation, skincare, agriculture, nutritional supplements, and plant-based consumables. Ultimately, Quanta’s mission is to deliver better, more effective ingredients to elevate product efficacy, reduce waste and facilitate healthier, more sustainable consumption.
The established resonance theory behind Quanta’s polarization process has many potential applications. From potentiating bio-ingredients to produce more-effective carbon-trapping plants to transformative anti-aging solutions Quanta’s technology has the opportunity to upend how commercial products are made and the benefits from them. Already we see multi-trillion-dollar global industries benefiting from Quanta’s technology.
Our proof of concept, Quanta’s market-leading CBD pain-relief rub (“Muscle Rub”), is only the first in a series of paradigm shift products to emerge from our labs. At the heart of its well-documented effectiveness is our proprietary “polarization” process, which uses electromagnetic force to markedly enhance bioactivity at the molecular level—a polarized active ingredient is more soluble and creates stronger bonds with the body’s receptors. This allows us to enhance ingredients so they work faster and more powerfully without the use of chemical by-products or cellular penetration. Quanta believes this natural solution has nearly limitless applications in the world of plant-based consumer products.
Quanta is involved in ambitious projects that we believe will reshape the next wave of climate science, sustainability, nutrition, and more. Having harnessed the technology of the future, Quanta is dedicated to bringing tomorrow’s health and wellness solutions to the billions in need today.
Discovery Synopsys
Using our product development process and business-to-business and direct-to-consumer sales approaches as a benchmark for future business, we developed the Quanta business model. Our technology’s unique ability to strengthen ingredients renders them more potent without added chemicals or penetrating cells means Quanta is in a first-of-its-kind position in the market. As the world’s first company focused on Quantum Biology we sit in a strong, but unique position in the market.
Our ability to increase ingredient efficacy by up to 500% means we are in a rare position to truly disrupt many areas of material science.
Quanta’s technology renders products superior to any on the market today. A 30% re-purchase rate (on one SKU alone) illustrates consumer appetite for the product.
Upcoming products and ventures will be designed to achieve or surpass this level of consumer benefit and uptake.
Quanta Business Model in 3 P’s: Potentiation, Partners, and Profits
After two years we believe the best possible model for the long-term success of the company is collaborating with best-in-class partners through joint ventures for new verticals, products, and research. These joint ventures may involve a jointly owned special purpose entity or they may be entirely based on contractual obligations.
Our mission has never been to create the best novel products on the planet. Our mission has always been to revolutionize the way formulations are developed and how products perform. We seek to work with the best product makers in the world to positively impact as many industries as possible.
The unique ability to increase the ingredient and product performance opens the doors for major opportunities. Higher performing ingredients mean less is needed to make a strong impact (increased margins, increase overall efficacy). We proved this with our Muscle Rub, which uses approximately 1/3 the CBD of competing products with demonstrably improved results.
The level of potentiation delivered by Quanta allows our partners the unique ability to provide higher-performing products, lower material costs, more competitive pricing and increased profit margins. In short, our partners will be able to make better performing, more affordable products with a higher repeat purchase. This is true disruption and consumer utopia.
We aim to work with groups that specialize in manufacturing, marketing, selling and distributing existing product lines that utilize ingredients we can potentiate. Partners like this facilitate efficient market delivery of joint innovations.
We believe this strategy provides greater shareholder value, enhances revenue potential, defrays upfront expenses and affords us the ability to raise capital for new projects without massive dilution.
Ultimately, these ventures would result in licensing out our technology to other reputable brands and companies to create co-branded products whereas the term “Powered by Quanta” becomes as recognized as “Intel Inside.”
https://sec.report/Document/0001493152-21-008846/
Medolife should be good-to-go with its application for an IND.
The IND application must contain information in three broad areas:
Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).
Manufacturing Information - Information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators--professionals (generally physicians) who oversee the administration of the experimental compound--to assess whether they are qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
The information below suggests that Medolife have already met or exceeded FDA requirements for an IND.
Medolife's Therapeutic Scorpion Peptide Proves Successful in Treating COVID-19 Patients in Dominican Republic Study
January 27, 2021
Medolife" a majority owned subsidiary of Quanta, Inc. today announced In a recent study, a total of 400 patients in the Dominican Republic - where, a majority tested positive for COVID-19, and a small portion were COVID-19 symptomatic even though they tested negative for COVID-19 - reported a 100 percent improvement in symptoms after being administered Escozine®. Many of the patients participating in the study reported severe COVID-19 symptoms, such as difficulty breathing, pain and high fever, which Escozine® was able to relieve within 5 days of treatment. Even patients under ventilators were discharged within days, thanks to this novel product. Located in Santo Domingo, Dominican Republic, The Cruz Jiminian Clinic has carried out this ongoing study since August 2020, and has reported 0 COVID-19 related deaths after the clinic began administering Escozine®. Escozine®, produced by Medolife Rx, Inc., ("Medolife"), is a therapeutic consisting of small molecule peptides derived from a specific species of scorpions, Rhopalurus princeps, endemic to the Dominican Republic. After the successful study, Escozine® is on fast-track to be registered with the Ministry of Health in the Dominican Republic in Q1 2021. Medolife also submitted the study data to the US FDA, which is currently under review for permission to repeat the clinical trial in the United States. In addition to supporting the recovery of COVID-19 patients, Escozine® was registered and certified for cancer treatment by the Ministry of Health in the Dominican Republic in 2010.
"The data proving the efficacy that Escozine has on a multitude of improved patient parameters is consistent with the rapid symptom relief I experienced while on site," said Dr. Annabelle Morgan, Cell and Developmental Biologist and one of Medolife's leading scientists. She noted, "What is even more astonishing is that 100% of patients tested negative for COVID-19 within 5-10 days of treatment."
"More importantly, all COVID-19 healthcare workers, including physicians and nurses, who took Escozine as a preventative, never tested positive" said Dr. Khalid Matalka, another leading scientist at Medolife, specializing in Cancer Therapy and Immunology. "The clinical trial results indicate that Escozine could be used as monotherapy or in combination with standard therapies against COVID-19, which will accelerate the healing from the virus. Besides, observations revealed that Escozine could be used as prevention from the COVID-19 infection."
Scorpion Venom Most Expensive Liquid in the World
From treating cancer to pain management to fighting viral infections, this unique peptide has a vast range of therapeutic applications. In the last decade, a growing interest from Big Pharma companies has caused an increase in the liquid's value: costing $39 million per gallon.
Medolife's Dominican Republic Scorpion Reservation is one of the largest breeding grounds for scorpions on earth. Combined with the company's more than 15 years of research, Medolife is positioned to continue developing groundbreaking formulas and pharmaceutical-grade medications for consumer use.
Medolife Rx Announces Positive Results in Clinical Safety Study on Its Polarized Drug Candidate for the Treatment of COVID-19
Medolife" a global integrated bioceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. announced today positive results in a safety and toxicity study conducted on its polarized drug candidate derived from a small molecular peptide found in scorpions, designed to treat patients with the SARS-CoV-2 virus, also known as COVID-19. The results showed no signs of toxicity in any of the patients involved in the study who were given the drug Escozine®, which is a polarized solution of the Rhopalurus princeps scorpion peptide owned by Medolife.
The study, which was conducted in Santo Domingo of the Dominican Republic under the supervision of medical principal investigators, was conducted on over 500 patients, where data from one group of patients was used in the Company’s FDA pre-IND filing. Each patient was given Escozine® sublingually four times a day. During and after administration, a complete blood count (CBC) was conducted on each patient where the researchers measured various parameters to evaluate if the drug candidate was safe, such as hemoglobin (Hb), hematocrit (HCT), and red blood cells (RBCs) levels. There were no significant differences observed before or after administration. Additionally, there were no significant differences observed in white blood cells (WBCs), neutrophils, lymphocytes, monocytes, or eosinophils, concluding that the drug candidate was safe and non-toxic.
“A successful safety study is a pivotal step in the clinical development program for a new drug candidate and we could not be more enthusiastic about our results,” said Medolife CEO Dr. Arthur Mikaelian. “While our near-term goal is to work with the Ministry of Environment of The Dominican Republic to bring this drug to market, we are able to use this data in our programs around the world, including with our submissions to the United States Food and Drug Administration. While there is significant research that suggests the potential therapeutic benefits of extracted scorpion peptide, when paired with our proprietary polarization technology that increases efficacy and bioavailability in the body, we believe our product Escozine® could be a true breakthrough in the field of medicine with applications in a variety of focus areas and indications.”
The Company is currently involved in various clinical studies on Escozine® around the world. It is seeking product registration in the Dominican Republic for treatment of COVID-19 where this study took place, while simultaneously seeking approval in the United States, where it has filed data on Escozine® with the US Food and Drug Administration (FDA) as a Pre-Investigational New Drug (PIND #150335) as a COVID-19 therapeutic. Registration in the Dominican Republic would act as a proof-of-concept on the drug that would propel it forward in its path to market.
Medolife’s patented polarization technology increases the potency of single molecules and complex compounds. This technology is already used in various Medolife products, ranging from supplements to drug candidates.
Medolife Rx Submits Final Data Set to FDA for IND Filing on Lead Drug Candidate
April 13, 2021
The Company assembled detailed information regarding the manufacturing of Escozine®, clarity on dosing, as well as both previous and new safety and efficacy data derived from an on-going human study taking place in the DR. The study has been conducted on over 500 participants and intends to demonstrate the safety and efficacy of Escozine®. Escozine® is a polarized solution of the Rhopalurus princeps scorpion peptide owned by Medolife, which has been filed with the FDA under the IND regulatory pathway as well as the Ministry of Health in the DR where the Company is seeking product registration. Previous clinical data was submitted to the FDA including preliminary results of the safety study, which has now been expanded upon. This data, as well as the batch of Escozine® that was produced specifically for the FDA, has now been submitted. After the review of the data and barring any further inquiries or requests, the FDA will designate IND status for Escozine®, essentially allowing the drug to be distributed in the US. After such designation, the Company will pursue other clinical applications of Escozine®, including as a potential cancer therapeutic where the Company has already released positive clinical results.
“The FDA-approved therapeutic drug market is the gold standard globally and should we receive IND designation from the FDA, it would catapult our other research across the world,” said Medolife CEO Dr. Arthur Mikaelian. “Submission to the FDA is never easy, but we are generating such positive clinical trial results that we are confident the regulatory body will take notice. They have been reviewing our submission for some time, requesting various other information that we have now submitted. I believe this could be the last request ahead of approval, which would be tremendous not only for our Company, but for patients who are in need of a solution where one does not currently exist. An approval from the FDA would also propel interest from the scientific community on the potential therapeutic benefits of the natural peptides we are studying, including investment and partnership interest.”
The Company has conducted extensive clinical studies on Escozine® as a therapeutic for both COVID-19 and multiple forms of cancer in the US and globally. It is seeking product registration in the DR for treatment of COVID-19 through its exclusive relationship with the Ministry of Health. Escozine® utilizes a patented polarization technology developed by Dr. Mikaelian that increases the potency of single molecules and complex compounds.
https://www.otcmarkets.com/stock/QNTA/news/story?e&id=1862474
News Feature: Venom back in vogue as a wellspring for drug candidates
How a new wave of research on venoms from an array of creatures could seed future pharma development.
Pediatric neurosurgeon Amy Lee works by the small, bright light of a microscope, her gaze focused on the opened skull of a child. Lee moves her hands calmly and confidently over the exposed brain, plucking out as much tumor as she safely can.
A handful of promising new drug candidates are derived from peptides in the venom of scorpions and other animals. Image credit: Shutterstock/Bens_Hikes.
But there are some surgeries, and some parts of the brain, where tumor tissue and healthy tissue look very much alike. In those cases, Lee, based at Seattle Children’s Hospital in Washington, looks to a computer monitor beside the operating table, where a view of the brain shows tumor, illuminated in fluorescent green, nestled in otherwise white, healthy tissue. This new diagnostic tool helps surgeons gauge, in real time, how much tumor they’ve removed, and how much is left behind.
Drug candidate tozuleristide, derived from scorpion venom, glows green in breast tissue removed during a lumpectomy surgery. Image credit: Blaze Bioscience.
That green glow comes from tozuleristide, a new diagnostic drug in phase two clinical trials. But the drug’s novelty stems not only from its potential to highlight troublesome childhood tumors, but also from the compound’s source: the potent venom of the Israeli deathstalker scorpion (Leiurus quinquestriatus).
Tozuleristide uses a peptide from the venom and an infrared dye to seek out and illuminate tumors of all kinds, including in the breast, colon, and skin. The drug has gone through safety testing and early clinical trials to image brain tumors in children, and today stands about two years from possible US Food and Drug Administration (FDA) approval. The key ingredient, the scorpion venom peptide chlorotoxin, is just one of many untapped, and potentially lifesaving toxins in the venom of snakes, scorpions, spiders, and other creatures, honed through millions of years of evolution to immobilize prey or fend off predators.
Now, the pharmaceutical industry has a growing interest in venom, as some companies opt to return to drug discovery inspired by natural compounds, a trend that fell out of fashion about 40 years ago. Excitement about drugs such as viper venom-inspired captopril in the early 1980s waned a few years later in favor of less complex synthetic small molecules that chemists could dream up in a lab. The industry sank billions of dollars into designing small molecules, often inspired by the molecular structure of existing medicines, but otherwise lacking biological context, “and none of it worked,” says chemical biologist Mandë Holford, who studies terebrid snail toxins at Hunter College, the American Museum of Natural History, and Weill Cornell Medicine in New York City.
“Over the last few years it has felt like there’s a push back to natural products,” adds biologist and biochemist Helena Safavi at the University of Copenhagen in Denmark. Biting, stinging organisms have had millions of years to evolve an array of toxins that act on specific physiological pathways, she notes. Often these toxins have clear potential to treat human disease. She calls them a “treasure trove for biomedical explorations.”
Yvonne Angell, the head of peptide chemistry at ChemPartner in South San Francisco, CA, also attributes the trend to advances in affordably mass-producing peptide-based drugs, and in slowing the peptide’s breakdown in the gut or bloodstream, allowing these compounds more time than ever to act as therapeutics in the body. Better tools to characterize small volumes of venoms also let researchers study never-before-investigated peptide toxins, from tiny critters such as centipedes that produce a miniscule amount of poison (1).
Slow Burn
People have used venoms as medicines for thousands of years. In India, needles dipped in snake venom feature in a fiery kind of Ayurvedic acupuncture to treat joint pain and inflammation (2, 3). In China, dried venoms from the lumpy brown skins of toads are traditional anticancer treatments (4). In Southeastern Mexico, a beverage of mashed tarantula, alcohol, and herbs traditionally treats chest pain and asthma (5). Western medicine’s interest in venom grew from traditional uses and blossomed in the early 1980s with the advent of the first venom-derived drug, captopril.
Captopril was conceived as a specific enzyme inhibitor, according to the drug’s codevelopers (6). The researchers collaborated at the Squibb Institute for Medical Research in New Brunswick, NJ, beginning in the 1960s. Captopril’s key ingredient, inspired by a peptide in the Brazilian jararaca pit viper’s venom, binds and blocks the active site of angiotensin-converting enzyme (ACE), preventing release of a peptide hormone that causes blood vessels to constrict. When taken orally, captopril lowers high blood pressure by relaxing the circulatory system, explains Glenn King, a biochemist at the University of Queensland outside Brisbane, Australia. Having studied venom toxins since 1995, he’s seen the FDA approve nine more venom-derived drugs, with the most recent approval in 2012. At least one more venom-derived drug, batroxobin, is available outside of the United States (7).
All 10 FDA-approved medications are based on venom peptides or larger proteins, the main ingredients in the cocktail of toxins delivered by a bite or sting. Peptides and proteins are stable in the body, and highly specific, often acting on just one or several kinds of membrane protein, ion channel, enzyme, or other binding site.
Take spiders, for example: They’ve had 400 million years to evolve hundreds of venom peptides, many of which act on nervous system ion channels. Some tarantula venom peptides that King is now studying selectively bind and inactivate one ion channel involved in pain signaling to paralyze their prey, by binding voltage sensors outside of the pore, which can selectively shut off the channel.
Pharmaceutical companies have tried with limited success to develop a drug inhibiting the same kind of ion channel—using drugs to block the channel’s pore, “like a cork in a wine bottle,” King says. The trouble with that approach: Pore-blocking synthetic small-molecule drugs can’t distinguish between the pores. King wanted a more selective molecule than a pore binder, and found that the tarantula venom peptides bind much more specific voltage sensors. Now, he is exploring the tarantula venom peptides as highly specific channel inhibitors that could one day be new painkillers. In a 2017 study on the venom of the giant blue bloom tarantula, King and collaborators found one such peptide, at least 40 times more selective for the pain channel than for any other channels (8). However, there’s plenty of work to be done—the same study found that the peptide may not completely inhibit the channel in vivo.
Painkillers could also come from the toxins of scorpions, wasps, bees, and ants, all of which use venoms that primarily target the nervous system. Toxins from snakes have more potential as therapeutics for heart attack and stroke, because they affect the cardiovascular system.
And one recently discovered ingredient in marine cone snail venom could offer a promising avenue for diabetes treatments. The coral reef-dwelling geographer cone has a wicked means of attack: The cone releases a cloud of insulin to incapacitate small prey fish by crashing their blood sugar. In work carried out at the University of Utah in Salt Lake City since the mid-2010s, Safavi has shown that the snail insulin acts in seconds on the human insulin receptor (9), likely because the snail’s insulin lacks a clunky hinge-like structure that other insulins require for binding. In a study published earlier this year, Safavi discovered two more fish-hunting cone snails that also have fast-acting insulins (10). Although these venoms may bring instant death to little fish, Safavi thinks they could offer fast-acting new medicines to diabetics, whose therapies typically take 15 to 90 minutes. Safavi says she and collaborators recently licensed a compound inspired by snail insulin to a small San Francisco, California-based biotech company called Monolog, which is leading the compound’s drug development in the lead-up to clinical trials.
Feeling the Heat
Despite the growing interest, only 10 drugs have received FDA approval for venoms since 1981, and the last one was more than eight years ago. “Certainly the techniques and processes are much better,” to develop venom-based drugs, King says. “So you’d think we’d be doing better, not worse.”
He sees no smoking gun, but suspects that the drug drought comes partly “because we’re going for harder things.” Many of the earliest venom-based drugs acted on enzymes in the cardiovascular system, such as clotting enzymes, he notes, which tend to have just one or several subtypes for a drug to target. Now drug development is looking to target diseases of the nervous system, which entails designing drugs that can act selectively on ion channels that can have dozens of hard-to-distinguish subtypes. Designing drugs to target such diseases in the brain is harder still, because the therapeutic compounds must cross the highly selective blood–brain barrier.
The consequences of a drug binding the wrong target are also more dangerous in the nervous system, King notes, where side effects can include paralysis or even death. Mistakes in the cardiovascular system are usually more fixable, because existing drugs can reverse excessive clotting or bleeding. This confluence of challenges has waylaid new toxin drug development.
A few drug candidate contenders could break the dry spell. Tozuleristide is one of them. So far it’s the only fluorescent brain tumor-imaging agent for kids. The drug completed phase one clinical trials in pediatric brain cancer patients in 2018, demonstrating that it’s safe to use in surgery. Neurosurgeon Lee at Seattle Children’s is now leading a phase two trial, in collaboration with surgeons at nine hospitals around the country, to determine how well tozuleristide illuminates tumor tissue rather than healthy brain.
Lee uses tozuleristide to complement her expert judgment, to cross-check how much tumor she has already removed, and how much tumor remains. If, during surgery, there’s no green glow left on the monitor beside her, “then I know I’ve gotten all of it,” Lee explains. “Or if it’s not safe to remove, we’re aware we left tumor there,” she adds. The troublesome tissue could then be treated with radiation or chemotherapy.
A few miles away from Lee’s operating room, Blaze Bioscience of Seattle, WA, is working to develop tozuleristide. President and CEO Heather Franklin estimates that the drug, if approved for pediatric brain cancer and eventually for most solid tumor cancer surgeries, could be useful to about two million patients per year in the United States and Europe.
What makes tozuleristide unique, says Blaze cofounder Jim Olson, is that its venom peptide chlorotoxin is retained in tumors and can cross the blood–brain barrier. Exactly how the toxin does this, and how it invades tumor cells—not only in the brain, but throughout the body—remains unclear. Olson, whose lab at the nearby Fred Hutchinson Cancer Research Center in Seattle created the molecular proof of concept for the drug, suspects that chlorotoxin’s tight, knot-like shape protects it from enzymes that would degrade the peptide, and may help it slip across the blood–brain barrier.
A Wide Web
Several other toxins are also snaking through clinical trials, including a drug candidate called dalazatide, inspired by the venom of the Caribbean sun sea anemone. From above, the anemone’s soft bed of yellow-green tentacles look spongy and inviting, but they pack a nasty sting, strong enough to kill little prey fish.
One component of the anemone’s sting, a peptide called ShK, shows promise to treat autoimmune diseases, including lupus, type 1 diabetes, inflammatory bowel disease, psoriasis, and multiple sclerosis (11). The peptide’s power comes from its ability to bind and block a potassium channel involved in autoimmune disorders. Blocking this channel, which is common on the surface of certain T cells, stops the cells from triggering the hallmark inflammation of autoimmune diseases, explains immunologist Michael Cahalan at the University of California, Irvine.
Background Information on the Blue Scorpion Venom worth 39 Million Dollars a Gallon:
Blue Scorpion Venom: Cuba's Miracle Drug
Six-year-old Leandro Gonzáles sits attentively at the foot of his parents' double bed, his legs dangling along the faded flower-print bedspread. His tiny brown eyes follow Dr. Niudis Cruz's index finger left, right, up, and down. He rolls back and stretches his arms toward the ceiling for a count of ten. Then Dr. Cruz, a sandy-haired cancer specialist in her 40s, slips her lean fingers into the small boy's hands, and he squeezes tightly. "Good, good," the doctor says, nodding.
Yaima, the boy's quiet, petite mother, stands to the side, holding her breath as Leandro completes his bimonthly physical exam. Her boy has an inoperable tumor in his brain stem, and she's watched the ritual countless times. But seeing him push his legs forcefully against the doctor's hand still brings tears of relief to her eyes. A little more than a year ago, he was immobile and virtually mute.
When the exam concludes, Cruz rattles off doctor-speak about the child's muscle strength, response mechanisms, and the Lansky scale, an internationally recognized quality-of-life indicator for child cancer patients (he's a 90; 100 is perfect health). She whips out her laptop and pulls up the black-and-white CT scan images of Leandro's brain. "His is the most aggressive of all pediatric cancers, with an 80 percent mortality rate within one year," she says.
She points toward the images on the screen and measurements of the tumor's progression since its detection 18 months ago. From September 2011 to April 2012, it decreased in size approximately 15 percent. During that period, Leandro underwent no treatment other than swallowing doses of clear, tasteless liquid three times daily. "It's scientifically impossible for a tumor to shrink on its own," the doctor emphasizes. "It has to be the result of some outside intervention."
Intervention for Leandro has been the venom of a medium-size scorpion called Rhopalurus junceus, known in Cuba as the escorpión azul — blue scorpion. Four months after he was diagnosed in May 2011, Leandro's weight had fallen to that of a 2-year-old. But after consuming the venom-water mixture, his health has returned almost to normal. He can now walk and tell you about his favorite food (sunny-side-up eggs) and color (yellow), and he rides his bike (with training wheels) daily. "I give thanks to God," Yaima says, "and to the doctors who knew about the scorpion."
For more than 20 years, Cubans have been treating cancer patients with blue scorpion venom. And there have been too many Leandros to dismiss the miraculous recoveries as coincidence. Even when the results aren't quite as jaw-dropping, thousands attest to pain relief, increased muscle strength, and renewed energy while on the medicine.
The treatment is now poised for a global premiere. Cuba's state pharmaceutical company, Labiofam, recently began mass-producing a homeopathic version called Vidatox. A handful of countries have registered it for sale, and a small black market to move the product around the globe has emerged. It's impossible to know how many patients have imbibed the venom treatment from the small glass bottles over the past two decades, but the number is likely more than 55,000 globally.
Curing cancer such as Leandro's has arguably become the medical world's greatest conundrum. According to the World Health Organization, the disease killed approximately 7.6 million people in 2008, 13 percent of all deaths worldwide. Despite the billions of dollars invested in research, our treatment fallbacks — chemotherapy and radiation — are woefully inadequate. Doctors are only 7.3 percent more successful at treating cancer than they were in 1950, and it's expected that by 2030, twice the number of people will die from the disease as do today, predicts the World Health Organization.
"It's hard for people to let go of believing only in conventional treatments," says Labiofam's director, Dr. José Antonio Fraga, a big man with a big mustache. He speaks from behind his director-size desk at the sprawling state pharmaceutical company in Havana that, until recently, was best known for supplying 98 percent of Cuba's veterinary products.
He chooses his words carefully. "We have not found a cure, and we do not suggest that people refuse chemotherapy or radiation," he says. "But human medicine is based on evidence." And his evidence cannot be overlooked.
Perhaps the best-known case of blue scorpion success is that of Yarislenis Abreu, a shy 15-year-old who goes by "Yari" and lives in the third-floor apartment of concrete housing in the town of Valle Honda, near Cuba's western edge. She remembers being "a vegetable" just five years ago. The right half of her body was paralyzed, and she could form thoughts in her mind but couldn't express the words. At age 10, her brain tumor was growing weekly, radiation had failed, and her doctors sent her home to die.
Her mother, Iraíde, refused to give up hope and sent Yari's father on a mission: He was to bring back the scorpion medicine a fellow cancer patient's mom said could be obtained free in a nearby province. A month later, Iraíde recalls of her daughter, "She was yelling at me: 'Mom, get me out of this bed!'" Since then, Yari has learned to walk again and write with her left hand, because her right is still smaller and weaker from the paralysis. She studies with a state-paid tutor at home and hopes to start normal high school soon. She has not missed a day of the venom medicine — and has a new weekly routine. Saturday nights, she walks two miles roundtrip to the nearest reggaeton dance club. "My mom jokes that it's like my church," Yari says, "because I go every weekend without fail."
That she, like Leandro, survived a brain tumor with the help of the venom is telling, says Dr. Alexis Diaz, an enthusiastic young Cuban scientist who's on Labiofam's small venom-research team. He says the medicine has produced results only on solid or organ cancers like those in the lungs, pancreas, brain, or stomach. It hasn't been found effective for liquid or blood-based cancers such as leukemia or lymphoma. Nor does the medicine always yield results like those that occurred with the two children. "Most patients seek the venom after everything else has failed," Diaz says. "These patients have very weak immune systems and the cancer has already metastasized, so it's hard to expect really surprising results every time."
But if the treatment is administered in the early stages of sickness, its impact is more profound, he believes. "We hope to help turn cancer from being a fatal disease into a chronic and manageable one, like diabetes."
Along these lines, Cuban doctors actively encourage using the venom as a complement to conventional methods. For example, after taking the venom for seven months, Leandro was strong enough for surgeons to create a permanent solution to his brain-fluid buildup. So his physicians, while maintaining his scorpion treatment, started him on radiation. This led to a further reduction in the tumor's size.
Dr. Luigi Di Lorenzi, director of the neuroscience department's rehabilitation unit at the Azienda Hospital G. Rummo in Benevento, Italy, tells a similar story. Unbeknownst to him, in 2010, one of his cancer patients began taking the venom-based formula. "My patient experienced an unexpected total pain relief with a good recovery of muscle strength, vital energy, and capacity to cope with daily activities such as eating," Di Lorenzi recalls.
Impressed, the specialist in rehabilitative medicine traveled to Cuba to investigate. "It is difficult to determine where reality ends and fantasy begins," he says, but "the common denominator seems to be a significant reduction of pain obtained in 100 percent of patients."
This, he stresses, should not be underestimated: "Pain therapy [is] crucial," he says, explaining how he described his experience for the Open Cancer Journal. "We do not aim to promote unproven therapies, [but] this venom certainly warrants further investigation," he wrote in a letter published last year.
Labiofam claims to have studied the effects of the venom on 10,000 patients, including 3,500 foreigners. But there is no public compilation of the methodology or results. No independent experts have conducted experiments, and none of Labiofam's work has been submitted for publication in peer-reviewed journals.
The medical world is therefore skeptical. "Rhopalurus junceus, or blue scorpion venom, originated from Cuba... is often marketed as having anti-cancer, anti-inflammatory, and analgesic properties," reads the Memorial Sloan-Kettering Cancer Center website. "The manufacturers' research cannot be corroborated. Continued research... is needed."
What is established is the product's safety. Labiofam says it conducted toxicity tests before it began distributing it, and a reputable laboratory at the Biotechnology Institute of Mexico's largest university, Universidad Nacional Autónoma de México (UNAM), recently confirmed the venom formula to be nontoxic to mammals. Indeed, among thousands of online accounts of success or failure with the venom treatment worldwide, not one notes harmful side effects.
The harmlessness of the medicine, though, is curious considering its origins.
José Perera and Juan González race up the brambly hillside. It's late, almost noon, and their work will be more difficult when the midday sun sends their tiny, evasive targets out of sight. Lanky, with taut bronzed skin and matching buzzcuts, the two men in their early 40s make their way through spiny brush toward a cluster of rocks. They hold metal pincers in one hand and opaque plastic containers in the other. The pair crouches in unison, carefully yet quickly pushing aside rocks. After a few moments, a small wriggling mass appears. As if sensing something ominous, the scorpion scurries frantically. But these men are professionals. With one motion, Perera steadies his pincers. He quickly grabs the scorpion's tail, thus rendering it as harmless as a grasshopper, and drops it into the container.
"I'm a scorpion hunter!" Perera says with gusto, stretching his back and surveying the rolling hills of Cuba's Santa Clara valley. The duo is one of a dozen or so teams that spend their days scouring rocks throughout the country in search of the misnamed scorpion, which is actually beige and mauve, not blue.
Back at González's nearby house, they add their catch to the dozens already inside a large metal barrel, covered by several rusty slabs. No living creature could possibly escape. "I've been stung 13 times in five years," Perera says. But neither he nor González is afraid. Though the sting of R. junceus hurts like hell and can cause temporary numbness, it's not deadly to humans. "People hate these animals," Perera reflects, genuinely confounded. "I say, 'Bring on the scorpions!'"
Indeed, the scorpion might be one of the animal kingdom's most misunderstood creatures. Of the more than 2,000 species worldwide, only 20 to 30 are dangerous to humans, and in those cases, mainly to small children. Scorpions sting only when threatened.
They've also been used for centuries in healing. "One noticeable example is the use of Mesobuthus martensii in Chinese traditional medicine," says Jan Ove Rein, a senior research librarian at the Norwegian University of Science & Technology and editor of the website the Scorpion Files, which lists more than 25 species with medical applications ranging from pain relief to treatment for seizures and paralysis.
The complete history of how Cuba stumbled upon its curative arachnid might never be known. There's no written account, and the man who discovered the blue scorpion's powers, a biologist named Misael Bordier Chivas, died of a heart attack seven years ago. But the story goes something like this: While testing several snake, spider, and scorpion venoms for a variety of ailments during the 1980s for the University of Guantánamo, Professor Bordier noticed improvement in rats and dogs taking R. junceus venom. He expanded his experiments and soon saw tumors decrease in size.
In 1993, word of his research reached a hotel manager named José Felipe Monzón living on the other side of the country in a town called Jagüey Grande. Monzón's 15-year-old daughter, Niurys, had all but lost a four-year battle with pancreatic cancer that had spread to her liver and intestines. Unwilling to give up, Monzón traveled to Guantánamo and begged Bordier for some venom. The professor mixed the first human formula for the girl, who appears to be in good health today. (She declined a request for an interview.)
Labiofam approached Bordier several years later. The state firm began tests that confirmed the treatment's safety. Given the promising results, the company decided to make it available immediately. Because government health authorities couldn't approve the medicine for sale so quickly, the company found a loophole: It started distributing it free to anyone who gave informed consent in 2003.
That practice meant a large amount of venom was needed. To get it, Labiofam created a scorpionario in the city of Santa Clara, where today more than 7,000 of the creatures wriggle in individual plastic containers on metal shelves.
"This is where the milking happens," says Manuel Valdés, a veterinarian clad in medical scrubs, latex gloves, and a surgical cap and mask. He's standing inside a small bare room in the Labiofam outpost. In the adjoining acclimatized rooms (71.6 degrees Fahrenheit), every scorpion has an ID number, coded for its region of capture and date of entry. The animals spend 40 days in quarantine — long enough for any pregnant scorpions to give birth and for any potential illness to be detected. Then they enter the venom rotation.
The scorpion twists itself backward as one of Valdés' colleagues uses two long metal tongs to try to steady the five-inch arachnid. "It takes a certain technique," Valdés says. The man aims the tail over a small glass jar sitting in a bucket of ice, and the scientist steps on a pedal attached to an electro-stimulus machine. As a jolt transmitted through the tongs reaches the scorpion, it releases six to 12 "micro-drops" of milky-white venom. "Each scorpion is milked once a month for two years," explains Valdés, who says the average lifespan of R. junceus is ten years. "Then it's released back into the wild to repopulate the species." The venom moves on to Havana, where for years it has been diluted with distilled water depending upon a patient's condition.
As soon as Labiofam began production, news of the free treatment traveled quickly. "I'd arrive at the office at 6 a.m. and there would already be lines of people around the block," Dr. Fraga recalls. Charter flights full of cancer patients started arriving from Europe. Weeks after an Italian journalist aired a video segment about the venom, hundreds of Italians showed up each day. "We never turned anyone away," Fraga says.
By 2010, the situation had become untenable. First, the government was anxious. In 2004, 2006, and 2009, Cuba's State Control Center for Medicine, Equipment, and Medicinal Products (CECEMD) — the country's equivalent of the Food and Drug Administration — was compelled to issue warnings regarding scorpion treatment. "Cuba does not yet have any pharmaceutical product based on the venom of the blue scorpion," Dr. Rafael Pérez Cristiá, director of Cuba's Regulatory Bureau for the Health Protection and Center for Quality Control, said in 2009. "At this moment, we do not have the documented evidence of the therapeutic action... that would justify its safe and efficient usage."
And supplies were running short. "They would need more than the entire scorpion population in Cuba to keep up production," says a former Labiofam employee who asked that his name not be used.
So Labiofam opted for homeopathy. This approach quickly gained approval, and Vidatox was born. The extremely diluted solution made it more viable to mass-produce. The 30-milliliter bottle is now available at Cuban pharmacies at a cost of $220 for foreigners and 4 cents for Cubans. Labiofam still makes the original, drinkable formula but has stopped its all-access distribution program.
Another formula is in the works. Diaz's team has identified five proteins in the venom that have anti-tumor capacities and will use these as the basis for a recombinant or synthetic version. One of the proteins being researched is likely a peptide known as chlorotoxin (CTX), which can be derived from many scorpion species. It has been researched in relation to cancer for 20 years with limited results. Diaz says if these elements can be genetically cloned, the blue scorpions of the future will live in peace.
Perera, the scorpion trapper, might worry that these advances would put him out of a job — but he doesn't. He has something more important on his mind. "My father was diagnosed with prostate cancer about a year ago," he says, choking up. The elder Perera is undergoing chemo and drinking the venom daily. His son believes the fruits of his labor are helping his father feel stronger and more energetic. "I feel proud that I can be a part of bringing the scorpions to the people who need them."
Perera, González, and their fellow Labiofam employees who supply Valdés' scorpionario aren't the only ones scavenging Cuba's woods for venom producers. Every week, informal hunters make a drop-off on a dusty street at the edge of Jagüey Grande. There's a large scorpion engraved on the door of the home and, to the left, a sign that reads, "Escozul." It lists office hours and instructions for medical consultation in English. There's no doorbell on the steel gate that encloses the porch of the nicest house on the block.
When a guest arrives, a large dog barks and a clear-eyed young woman in her 30s greets us for José Felipe Monzón. "He doesn't talk to the press," the woman says politely. It's expected. He has already turned down interview requests.
So a last card is played: "Do you think maybe his daughter — the one he saved with the scorpion venom years ago — might be willing to chat?"
The woman smiles shyly and apologizes: "Sorry, I don't give interviews either."
The story, though, has been told. The father began bringing back extra venom from Guantánamo. His daughter improved. Neighbors and friends were impressed with the girl's recovery, and Bordier finally taught Monzón the recipe. Monzón soon set up a home office and started calling the medicine "escozul" (a blend of the words escorpión and azul).
"Lines around the block!" says Arturo Fernández, Monzón's next-door neighbor for the past three decades. "Italians, French, Australians, people from everywhere started arriving." Locals too.
But those who don't have the time or money or health to get to the tiny island have few other options. A handful of doctors outside Cuba administer the treatment, including a California oncologist who had an integrative-medicine practice in Tijuana, where he treated several patients from the States. "At first, we witnessed remarkable recoveries," Dr. Santiago Vargas wrote in an email, noting that he discovered escozul in 2005 and that his practice closed in 2011, but he did not indicate a reason. "Still, as we continued to recommend it, we found some inconsistency in the results; apparently it worked best for [gastrointestinal] tract cancers. I was told it worked well for most other forms of cancer; this was not our experience." He obtained the venom from Mexico City, where there's another physician who travels to Cuba every three months and claims to make the venom in collaboration with Bordier's son.
Those who can't travel to see these physicians must place their faith in online third parties. Labiofam has secured homeopathic licenses for Vidatox in 22 countries: China, Albania, and several in Latin America. The company's website lists official distributors for these nations. But because neither the United States nor Canada nor any European state has cleared Vidatox through a rigorous homeopathic standards process, venom seekers must rely on the black market.
"I have organized it for people in Europe, the USA, Vietnam, China, the Arabian States, Africa, Australia," says a German man named Oliver Binnenböse, who for 950 euros (about $1,200) will travel to Cuba and then deliver to you three bottles of Vidatox. He's one of many people who offer these services on cancer-treatment chat forums. With such small quantities, he has never had any problems slipping under customs' radar.
Spiros Anagnostopoulos, who's from Greece, similarly transferred the medicine to a cancer patient he met on his first trip to Cuba in 2005 and who couldn't afford to go back for his resupply.
A more troubling black market, however, is emerging. In 2011, Italian police confiscated 236 bottles of Vidatox — more than $50,000 in resale value — being smuggled in from Albania, an easy access point of entry into Europe.
"[The confiscated material] is not a drug," Silvio Garattini, founder and director of the Mario Negri Institute of Pharmacological Research in Milan, said in a statement soon after, but rather "a preparation that has not been approved by any international regulatory agency." The Italian government's Natural Substances and Traditional Medicines Unit of the Italian National Institute of Health thought it wise to weigh in as well: "Despite the potential benefits of the registered drug, clinical trials in accordance with official protocols have not been so far undertaken, and it should be mandatory to achieve an appropriate European evaluation of this product," the 2011 statement read.
Labiofam says it laments the trafficking and is seeking approval in dozens of other countries, but it won't specify which are under way.
A plethora of websites offer to send the original drinkable formula — referred to as escozul, escoazul, or the trademarked Escozine — anywhere in the world. Some sites seem more trustworthy than others, such as LifEscozul, which claims to work in direct coordination with Monzón and Bordier's family. "We service mainly Europe," says LifEscozul's managing director, Ariel Portal, whose agency can either arrange travel to Cuba or deliver copies of the patient's medical history to the producers so they can prepare a personalized treatment for shipment.
It's particularly complicated for patients in the United States because an embargo prohibits any product of Cuban origin — be it medicine, a cigar, or a T-shirt — from entering the country, but companies say they have ways of getting the product to clients in the States regardless.
Physicians both on the island and abroad are careful in their judgment of the blue scorpion toxin. Questioned about the venom, several of Cuba's leading scientists shifted in their chairs. They have a powerful international reputation to protect. When the island lost its Soviet income in the 1990s, Fidel Castro's government decided to invest heavily in biotechnology as a potential long-term industry. The gamble paid off: Cuba has developed a top-tier research program and landmark achievements to show for it. Cuban scientists discovered the world's first human vaccine with a synthetic antigen for Haemophilus influenzae type B. They publish frequently in prestigious journals and have hundreds of patents in more than 50 countries for 13 different oncologic, autoimmune, infectious-disease, and cardiovascular projects. Their efforts are often lauded by U.S. and European scientists as well as international agencies such as the World Health Organization.
As the scorpion's fame outpaces other, more proven Cuban medical discoveries, there's worry that the little-studied natural treatment could tarnish the country's hard-earned reputation — or, worse, do greater harm. When a Greek TV program more than a decade ago highlighted a young boy who had been saved by Monzón's venom, Monzón told the media at the time: "Now half of the world is coming to see me. I don't want to raise people's expectations."
Indeed, every cancer expert consulted for this article, even those who have witnessed remarkable results, agrees that prudence is the best option. "It is wrong to play with the hopes of people in such desperate situations," says Di Lorenzi, the Roman doctor.
Back at his house, Leandro wears a jean jacket to protect against the Cuban winter's cool breeze. He's playing with his pet turtle. "I named her Cuca!" he says excitedly. The boy was sad to see his dog go when he became ill, but his mom was concerned that the fur and dirt might threaten her son's fragile health. Similarly, Leandro's parents keep him away from large crowds.
Yaima also prefers that he ride his bike only in the backyard. "Just until he gets better," she says, though no one knows whether he will make a full recovery. She doesn't seem bothered by the uncertainty; she began this therapy with her eyes open and knows there are no guarantees. She's just glad her son has a shot at surviving.
As a reporter and a photographer prepare to leave, the boy gives high-fives. Then he slaps the hand of the driver, whom he'll see again soon: It's the same driver in the same white van that drops off his free medicine a few times a month. Leandro thought New Times was there to take him for a visit to his physician. The miracle child can't conceive of his questionable future. But he already knows what he wants to be when he grows up: "a doctor."
https://www.miaminewtimes.com/news/blue-scorpion-venom-cubas-miracle-drug-6391741
May 11, 2021
What animal venom is used in medicine that is approved by the FDA?
Approved Drugs. Among the 11 approved toxin-based molecules marketed, one molecule (ziconotide) is obtained from cone snails, two from lizards (exenatide and lixisenatide), two from leeches (bivalirudin and desirudin), and six from snakes (captopril, enalapril, tirofiban, eptifibatide, batroxobin, and cobratide).
May 13, 2021
Approved Drugs. Among the 12 approved toxin-based molecules marketed, one molecule (ziconotide) is obtained from cone snails, two from lizards (exenatide and lixisenatide), two from leeches (bivalirudin and desirudin), and six from snakes (captopril, enalapril, tirofiban, eptifibatide, batroxobin, and cobratide). One from the Caribbean Blue Scorpion (Escozine).
The Escozine® therapeutic will be the FIRST ever Scorpion Venom approved by the FDA.
Why is this a BIG deal?
Scorpion Venom Most Expensive Liquid in the World
From treating cancer to pain management to fighting viral infections, this unique peptide has a vast range of therapeutic applications. In the last decade, a growing interest from Big Pharma companies has caused an increase in the liquid's value: costing $39 million per gallon.
May 11, 2021
What animal venom is used in medicine?
Approved Drugs. Among the 11 approved toxin-based molecules marketed, one molecule (ziconotide) is obtained from cone snails, two from lizards (exenatide and lixisenatide), two from leeches (bivalirudin and desirudin), and six from snakes (captopril, enalapril, tirofiban, eptifibatide, batroxobin, and cobratide).
May 13, 2021
Approved Drugs. Among the 12 approved toxin-based molecules marketed, one molecule (ziconotide) is obtained from cone snails, two from lizards (exenatide and lixisenatide), two from leeches (bivalirudin and desirudin), and six from snakes (captopril, enalapril, tirofiban, eptifibatide, batroxobin, and cobratide). One from the Caribbean Blue Scorpion (Escozine).
The Escozine® therapeutic will be the FIRST ever Scorpion Venom approved by the FDA.
Why is this a BIG deal?
Scorpion Venom Most Expensive Liquid in the World
From treating cancer to pain management to fighting viral infections, this unique peptide has a vast range of therapeutic applications. In the last decade, a growing interest from Big Pharma companies has caused an increase in the liquid's value: costing $39 million per gallon.
First FDA approval for Escozine® use for Covid 19 (Big)
Second FDA approval for Escozine® cancer clinical trials (HUGE)
What may these approvals bring?
Once a medicine is approved by the FDA, it opens up the ability for Doctors to prescribe them for their patients and it opens up the POCKETBOOKS of Insurance companies to pay for them.
Medolife Rx Announces Pre-Clinical Results on Drug Candidate Escozine Showing Efficacy in Eliminating Cell Lines in Ovarian and Bladder Cancer
Medolife Rx Announces Pre-Clinical Results on Drug Candidate Escozine Showing Efficacy in Eliminating Cell Lines in Ovarian and Bladder Cancer
BURBANK, Calif., March 23, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire – Medolife Rx, Inc. ("Medolife"), a global integrated bioceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. (OTC PINK: QNTA), announced today clinical trial results conducted on its lead drug candidate Escozine® where the drug eradicated in vitro bladder (SCaBER) and ovarian (OVCAR-3 and IGR-OV1) cancer cell lines when administered for 24 hours.
The study was conducted at one of the most prestigious academic research facilities in the United States. The goal of the study was to assess the viability of human bladder and ovarian cancer cells treated with Escozine®, the Company’s polarized drug candidate derived from a small molecular peptide found in scorpions. It examined the effects of both polarized and non-polarized versions of the drug on the viability of cell walls, finding that only the polarized version had a significant effect on eliminating the cell lines in all three cancers. This highlights not only the potential of Escozine® as a treatment for cancer, but the increased efficacy and bioavailability of the drug through the polarization methodology unique to Medolife Rx. Cell lines are commonly used in in vitro model systems in many drug discovery research programs. They retain most of the genetic properties of the cancer of origin and provide researchers with an indefinite source of biological material for experimental purposes (source). This study was especially significant in that Escozine® eradicated the cell lines completely, furthering the hypothesis that the drug could eliminate cancer cells in humans completely as well.
“We could not be more pleased by the results of this research,” said Medolife CEO Dr. Arthur Mikaelian. “As we progress in our clinical research on Escozine®, where we are initially targeting product registration and approval for treatment of COVID-19, we are conducting ongoing research on its potential therapeutic benefits as a treatment for various other indications, including many types of cancer. In this study, our drug completely eliminated the cell lines of two types of cancer in three samples. These results are not just exciting, they could be the precipice for what could become an effective treatment for one of the largest health issues in the world. Beyond proving the peptides’ ability to eradicate cancer cell lines, the study also showed how effective our polarization technology is on increasing efficacy. With results like these, I could not be more confident in Escozine® as a viable treatment for a variety of health issues and we are so proud to continue to push it through clinical trials around the world.”
The Company is conducting concurrent clinical studies on Escozine® around the world in countries such as the Dominican Republic and the United States. It is seeking product registration in the Dominican Republic for treatment of COVID-19, where it recently announced positive efficacy and safety results on over 500 patients. Additionally, it has filed data on Escozine® with the US Food and Drug Administration (FDA) as a Pre-Investigational New Drug (PIND #150335) as a COVID-19 therapeutic and is hoping to receive a response in short order. Medolife utilizes a patented polarization technology in all of its clinical drug candidates and nutraceutical consumer products that increase the potency of single molecules and complex compounds.
Background Information on the Blue Scorpion Venom worth 39 Million Dollars a Gallon:
Blue Scorpion Venom: Cuba's Miracle Drug
Six-year-old Leandro Gonzáles sits attentively at the foot of his parents' double bed, his legs dangling along the faded flower-print bedspread. His tiny brown eyes follow Dr. Niudis Cruz's index finger left, right, up, and down. He rolls back and stretches his arms toward the ceiling for a count of ten. Then Dr. Cruz, a sandy-haired cancer specialist in her 40s, slips her lean fingers into the small boy's hands, and he squeezes tightly. "Good, good," the doctor says, nodding.
Yaima, the boy's quiet, petite mother, stands to the side, holding her breath as Leandro completes his bimonthly physical exam. Her boy has an inoperable tumor in his brain stem, and she's watched the ritual countless times. But seeing him push his legs forcefully against the doctor's hand still brings tears of relief to her eyes. A little more than a year ago, he was immobile and virtually mute.
When the exam concludes, Cruz rattles off doctor-speak about the child's muscle strength, response mechanisms, and the Lansky scale, an internationally recognized quality-of-life indicator for child cancer patients (he's a 90; 100 is perfect health). She whips out her laptop and pulls up the black-and-white CT scan images of Leandro's brain. "His is the most aggressive of all pediatric cancers, with an 80 percent mortality rate within one year," she says.
She points toward the images on the screen and measurements of the tumor's progression since its detection 18 months ago. From September 2011 to April 2012, it decreased in size approximately 15 percent. During that period, Leandro underwent no treatment other than swallowing doses of clear, tasteless liquid three times daily. "It's scientifically impossible for a tumor to shrink on its own," the doctor emphasizes. "It has to be the result of some outside intervention."
Intervention for Leandro has been the venom of a medium-size scorpion called Rhopalurus junceus, known in Cuba as the escorpión azul — blue scorpion. Four months after he was diagnosed in May 2011, Leandro's weight had fallen to that of a 2-year-old. But after consuming the venom-water mixture, his health has returned almost to normal. He can now walk and tell you about his favorite food (sunny-side-up eggs) and color (yellow), and he rides his bike (with training wheels) daily. "I give thanks to God," Yaima says, "and to the doctors who knew about the scorpion."
For more than 20 years, Cubans have been treating cancer patients with blue scorpion venom. And there have been too many Leandros to dismiss the miraculous recoveries as coincidence. Even when the results aren't quite as jaw-dropping, thousands attest to pain relief, increased muscle strength, and renewed energy while on the medicine.
The treatment is now poised for a global premiere. Cuba's state pharmaceutical company, Labiofam, recently began mass-producing a homeopathic version called Vidatox. A handful of countries have registered it for sale, and a small black market to move the product around the globe has emerged. It's impossible to know how many patients have imbibed the venom treatment from the small glass bottles over the past two decades, but the number is likely more than 55,000 globally.
Curing cancer such as Leandro's has arguably become the medical world's greatest conundrum. According to the World Health Organization, the disease killed approximately 7.6 million people in 2008, 13 percent of all deaths worldwide. Despite the billions of dollars invested in research, our treatment fallbacks — chemotherapy and radiation — are woefully inadequate. Doctors are only 7.3 percent more successful at treating cancer than they were in 1950, and it's expected that by 2030, twice the number of people will die from the disease as do today, predicts the World Health Organization.
"It's hard for people to let go of believing only in conventional treatments," says Labiofam's director, Dr. José Antonio Fraga, a big man with a big mustache. He speaks from behind his director-size desk at the sprawling state pharmaceutical company in Havana that, until recently, was best known for supplying 98 percent of Cuba's veterinary products.
He chooses his words carefully. "We have not found a cure, and we do not suggest that people refuse chemotherapy or radiation," he says. "But human medicine is based on evidence." And his evidence cannot be overlooked.
Perhaps the best-known case of blue scorpion success is that of Yarislenis Abreu, a shy 15-year-old who goes by "Yari" and lives in the third-floor apartment of concrete housing in the town of Valle Honda, near Cuba's western edge. She remembers being "a vegetable" just five years ago. The right half of her body was paralyzed, and she could form thoughts in her mind but couldn't express the words. At age 10, her brain tumor was growing weekly, radiation had failed, and her doctors sent her home to die.
Her mother, Iraíde, refused to give up hope and sent Yari's father on a mission: He was to bring back the scorpion medicine a fellow cancer patient's mom said could be obtained free in a nearby province. A month later, Iraíde recalls of her daughter, "She was yelling at me: 'Mom, get me out of this bed!'" Since then, Yari has learned to walk again and write with her left hand, because her right is still smaller and weaker from the paralysis. She studies with a state-paid tutor at home and hopes to start normal high school soon. She has not missed a day of the venom medicine — and has a new weekly routine. Saturday nights, she walks two miles roundtrip to the nearest reggaeton dance club. "My mom jokes that it's like my church," Yari says, "because I go every weekend without fail."
That she, like Leandro, survived a brain tumor with the help of the venom is telling, says Dr. Alexis Diaz, an enthusiastic young Cuban scientist who's on Labiofam's small venom-research team. He says the medicine has produced results only on solid or organ cancers like those in the lungs, pancreas, brain, or stomach. It hasn't been found effective for liquid or blood-based cancers such as leukemia or lymphoma. Nor does the medicine always yield results like those that occurred with the two children. "Most patients seek the venom after everything else has failed," Diaz says. "These patients have very weak immune systems and the cancer has already metastasized, so it's hard to expect really surprising results every time."
But if the treatment is administered in the early stages of sickness, its impact is more profound, he believes. "We hope to help turn cancer from being a fatal disease into a chronic and manageable one, like diabetes."
Along these lines, Cuban doctors actively encourage using the venom as a complement to conventional methods. For example, after taking the venom for seven months, Leandro was strong enough for surgeons to create a permanent solution to his brain-fluid buildup. So his physicians, while maintaining his scorpion treatment, started him on radiation. This led to a further reduction in the tumor's size.
Dr. Luigi Di Lorenzi, director of the neuroscience department's rehabilitation unit at the Azienda Hospital G. Rummo in Benevento, Italy, tells a similar story. Unbeknownst to him, in 2010, one of his cancer patients began taking the venom-based formula. "My patient experienced an unexpected total pain relief with a good recovery of muscle strength, vital energy, and capacity to cope with daily activities such as eating," Di Lorenzi recalls.
Impressed, the specialist in rehabilitative medicine traveled to Cuba to investigate. "It is difficult to determine where reality ends and fantasy begins," he says, but "the common denominator seems to be a significant reduction of pain obtained in 100 percent of patients."
This, he stresses, should not be underestimated: "Pain therapy [is] crucial," he says, explaining how he described his experience for the Open Cancer Journal. "We do not aim to promote unproven therapies, [but] this venom certainly warrants further investigation," he wrote in a letter published last year.
Labiofam claims to have studied the effects of the venom on 10,000 patients, including 3,500 foreigners. But there is no public compilation of the methodology or results. No independent experts have conducted experiments, and none of Labiofam's work has been submitted for publication in peer-reviewed journals.
The medical world is therefore skeptical. "Rhopalurus junceus, or blue scorpion venom, originated from Cuba... is often marketed as having anti-cancer, anti-inflammatory, and analgesic properties," reads the Memorial Sloan-Kettering Cancer Center website. "The manufacturers' research cannot be corroborated. Continued research... is needed."
What is established is the product's safety. Labiofam says it conducted toxicity tests before it began distributing it, and a reputable laboratory at the Biotechnology Institute of Mexico's largest university, Universidad Nacional Autónoma de México (UNAM), recently confirmed the venom formula to be nontoxic to mammals. Indeed, among thousands of online accounts of success or failure with the venom treatment worldwide, not one notes harmful side effects.
The harmlessness of the medicine, though, is curious considering its origins.
José Perera and Juan González race up the brambly hillside. It's late, almost noon, and their work will be more difficult when the midday sun sends their tiny, evasive targets out of sight. Lanky, with taut bronzed skin and matching buzzcuts, the two men in their early 40s make their way through spiny brush toward a cluster of rocks. They hold metal pincers in one hand and opaque plastic containers in the other. The pair crouches in unison, carefully yet quickly pushing aside rocks. After a few moments, a small wriggling mass appears. As if sensing something ominous, the scorpion scurries frantically. But these men are professionals. With one motion, Perera steadies his pincers. He quickly grabs the scorpion's tail, thus rendering it as harmless as a grasshopper, and drops it into the container.
"I'm a scorpion hunter!" Perera says with gusto, stretching his back and surveying the rolling hills of Cuba's Santa Clara valley. The duo is one of a dozen or so teams that spend their days scouring rocks throughout the country in search of the misnamed scorpion, which is actually beige and mauve, not blue.
Back at González's nearby house, they add their catch to the dozens already inside a large metal barrel, covered by several rusty slabs. No living creature could possibly escape. "I've been stung 13 times in five years," Perera says. But neither he nor González is afraid. Though the sting of R. junceus hurts like hell and can cause temporary numbness, it's not deadly to humans. "People hate these animals," Perera reflects, genuinely confounded. "I say, 'Bring on the scorpions!'"
Indeed, the scorpion might be one of the animal kingdom's most misunderstood creatures. Of the more than 2,000 species worldwide, only 20 to 30 are dangerous to humans, and in those cases, mainly to small children. Scorpions sting only when threatened.
They've also been used for centuries in healing. "One noticeable example is the use of Mesobuthus martensii in Chinese traditional medicine," says Jan Ove Rein, a senior research librarian at the Norwegian University of Science & Technology and editor of the website the Scorpion Files, which lists more than 25 species with medical applications ranging from pain relief to treatment for seizures and paralysis.
The complete history of how Cuba stumbled upon its curative arachnid might never be known. There's no written account, and the man who discovered the blue scorpion's powers, a biologist named Misael Bordier Chivas, died of a heart attack seven years ago. But the story goes something like this: While testing several snake, spider, and scorpion venoms for a variety of ailments during the 1980s for the University of Guantánamo, Professor Bordier noticed improvement in rats and dogs taking R. junceus venom. He expanded his experiments and soon saw tumors decrease in size.
In 1993, word of his research reached a hotel manager named José Felipe Monzón living on the other side of the country in a town called Jagüey Grande. Monzón's 15-year-old daughter, Niurys, had all but lost a four-year battle with pancreatic cancer that had spread to her liver and intestines. Unwilling to give up, Monzón traveled to Guantánamo and begged Bordier for some venom. The professor mixed the first human formula for the girl, who appears to be in good health today. (She declined a request for an interview.)
Labiofam approached Bordier several years later. The state firm began tests that confirmed the treatment's safety. Given the promising results, the company decided to make it available immediately. Because government health authorities couldn't approve the medicine for sale so quickly, the company found a loophole: It started distributing it free to anyone who gave informed consent in 2003.
That practice meant a large amount of venom was needed. To get it, Labiofam created a scorpionario in the city of Santa Clara, where today more than 7,000 of the creatures wriggle in individual plastic containers on metal shelves.
"This is where the milking happens," says Manuel Valdés, a veterinarian clad in medical scrubs, latex gloves, and a surgical cap and mask. He's standing inside a small bare room in the Labiofam outpost. In the adjoining acclimatized rooms (71.6 degrees Fahrenheit), every scorpion has an ID number, coded for its region of capture and date of entry. The animals spend 40 days in quarantine — long enough for any pregnant scorpions to give birth and for any potential illness to be detected. Then they enter the venom rotation.
The scorpion twists itself backward as one of Valdés' colleagues uses two long metal tongs to try to steady the five-inch arachnid. "It takes a certain technique," Valdés says. The man aims the tail over a small glass jar sitting in a bucket of ice, and the scientist steps on a pedal attached to an electro-stimulus machine. As a jolt transmitted through the tongs reaches the scorpion, it releases six to 12 "micro-drops" of milky-white venom. "Each scorpion is milked once a month for two years," explains Valdés, who says the average lifespan of R. junceus is ten years. "Then it's released back into the wild to repopulate the species." The venom moves on to Havana, where for years it has been diluted with distilled water depending upon a patient's condition.
As soon as Labiofam began production, news of the free treatment traveled quickly. "I'd arrive at the office at 6 a.m. and there would already be lines of people around the block," Dr. Fraga recalls. Charter flights full of cancer patients started arriving from Europe. Weeks after an Italian journalist aired a video segment about the venom, hundreds of Italians showed up each day. "We never turned anyone away," Fraga says.
By 2010, the situation had become untenable. First, the government was anxious. In 2004, 2006, and 2009, Cuba's State Control Center for Medicine, Equipment, and Medicinal Products (CECEMD) — the country's equivalent of the Food and Drug Administration — was compelled to issue warnings regarding scorpion treatment. "Cuba does not yet have any pharmaceutical product based on the venom of the blue scorpion," Dr. Rafael Pérez Cristiá, director of Cuba's Regulatory Bureau for the Health Protection and Center for Quality Control, said in 2009. "At this moment, we do not have the documented evidence of the therapeutic action... that would justify its safe and efficient usage."
And supplies were running short. "They would need more than the entire scorpion population in Cuba to keep up production," says a former Labiofam employee who asked that his name not be used.
So Labiofam opted for homeopathy. This approach quickly gained approval, and Vidatox was born. The extremely diluted solution made it more viable to mass-produce. The 30-milliliter bottle is now available at Cuban pharmacies at a cost of $220 for foreigners and 4 cents for Cubans. Labiofam still makes the original, drinkable formula but has stopped its all-access distribution program.
Another formula is in the works. Diaz's team has identified five proteins in the venom that have anti-tumor capacities and will use these as the basis for a recombinant or synthetic version. One of the proteins being researched is likely a peptide known as chlorotoxin (CTX), which can be derived from many scorpion species. It has been researched in relation to cancer for 20 years with limited results. Diaz says if these elements can be genetically cloned, the blue scorpions of the future will live in peace.
Perera, the scorpion trapper, might worry that these advances would put him out of a job — but he doesn't. He has something more important on his mind. "My father was diagnosed with prostate cancer about a year ago," he says, choking up. The elder Perera is undergoing chemo and drinking the venom daily. His son believes the fruits of his labor are helping his father feel stronger and more energetic. "I feel proud that I can be a part of bringing the scorpions to the people who need them."
Perera, González, and their fellow Labiofam employees who supply Valdés' scorpionario aren't the only ones scavenging Cuba's woods for venom producers. Every week, informal hunters make a drop-off on a dusty street at the edge of Jagüey Grande. There's a large scorpion engraved on the door of the home and, to the left, a sign that reads, "Escozul." It lists office hours and instructions for medical consultation in English. There's no doorbell on the steel gate that encloses the porch of the nicest house on the block.
When a guest arrives, a large dog barks and a clear-eyed young woman in her 30s greets us for José Felipe Monzón. "He doesn't talk to the press," the woman says politely. It's expected. He has already turned down interview requests.
So a last card is played: "Do you think maybe his daughter — the one he saved with the scorpion venom years ago — might be willing to chat?"
The woman smiles shyly and apologizes: "Sorry, I don't give interviews either."
The story, though, has been told. The father began bringing back extra venom from Guantánamo. His daughter improved. Neighbors and friends were impressed with the girl's recovery, and Bordier finally taught Monzón the recipe. Monzón soon set up a home office and started calling the medicine "escozul" (a blend of the words escorpión and azul).
"Lines around the block!" says Arturo Fernández, Monzón's next-door neighbor for the past three decades. "Italians, French, Australians, people from everywhere started arriving." Locals too.
But those who don't have the time or money or health to get to the tiny island have few other options. A handful of doctors outside Cuba administer the treatment, including a California oncologist who had an integrative-medicine practice in Tijuana, where he treated several patients from the States. "At first, we witnessed remarkable recoveries," Dr. Santiago Vargas wrote in an email, noting that he discovered escozul in 2005 and that his practice closed in 2011, but he did not indicate a reason. "Still, as we continued to recommend it, we found some inconsistency in the results; apparently it worked best for [gastrointestinal] tract cancers. I was told it worked well for most other forms of cancer; this was not our experience." He obtained the venom from Mexico City, where there's another physician who travels to Cuba every three months and claims to make the venom in collaboration with Bordier's son.
Those who can't travel to see these physicians must place their faith in online third parties. Labiofam has secured homeopathic licenses for Vidatox in 22 countries: China, Albania, and several in Latin America. The company's website lists official distributors for these nations. But because neither the United States nor Canada nor any European state has cleared Vidatox through a rigorous homeopathic standards process, venom seekers must rely on the black market.
"I have organized it for people in Europe, the USA, Vietnam, China, the Arabian States, Africa, Australia," says a German man named Oliver Binnenböse, who for 950 euros (about $1,200) will travel to Cuba and then deliver to you three bottles of Vidatox. He's one of many people who offer these services on cancer-treatment chat forums. With such small quantities, he has never had any problems slipping under customs' radar.
Spiros Anagnostopoulos, who's from Greece, similarly transferred the medicine to a cancer patient he met on his first trip to Cuba in 2005 and who couldn't afford to go back for his resupply.
A more troubling black market, however, is emerging. In 2011, Italian police confiscated 236 bottles of Vidatox — more than $50,000 in resale value — being smuggled in from Albania, an easy access point of entry into Europe.
"[The confiscated material] is not a drug," Silvio Garattini, founder and director of the Mario Negri Institute of Pharmacological Research in Milan, said in a statement soon after, but rather "a preparation that has not been approved by any international regulatory agency." The Italian government's Natural Substances and Traditional Medicines Unit of the Italian National Institute of Health thought it wise to weigh in as well: "Despite the potential benefits of the registered drug, clinical trials in accordance with official protocols have not been so far undertaken, and it should be mandatory to achieve an appropriate European evaluation of this product," the 2011 statement read.
Labiofam says it laments the trafficking and is seeking approval in dozens of other countries, but it won't specify which are under way.
A plethora of websites offer to send the original drinkable formula — referred to as escozul, escoazul, or the trademarked Escozine — anywhere in the world. Some sites seem more trustworthy than others, such as LifEscozul, which claims to work in direct coordination with Monzón and Bordier's family. "We service mainly Europe," says LifEscozul's managing director, Ariel Portal, whose agency can either arrange travel to Cuba or deliver copies of the patient's medical history to the producers so they can prepare a personalized treatment for shipment.
It's particularly complicated for patients in the United States because an embargo prohibits any product of Cuban origin — be it medicine, a cigar, or a T-shirt — from entering the country, but companies say they have ways of getting the product to clients in the States regardless.
Physicians both on the island and abroad are careful in their judgment of the blue scorpion toxin. Questioned about the venom, several of Cuba's leading scientists shifted in their chairs. They have a powerful international reputation to protect. When the island lost its Soviet income in the 1990s, Fidel Castro's government decided to invest heavily in biotechnology as a potential long-term industry. The gamble paid off: Cuba has developed a top-tier research program and landmark achievements to show for it. Cuban scientists discovered the world's first human vaccine with a synthetic antigen for Haemophilus influenzae type B. They publish frequently in prestigious journals and have hundreds of patents in more than 50 countries for 13 different oncologic, autoimmune, infectious-disease, and cardiovascular projects. Their efforts are often lauded by U.S. and European scientists as well as international agencies such as the World Health Organization.
As the scorpion's fame outpaces other, more proven Cuban medical discoveries, there's worry that the little-studied natural treatment could tarnish the country's hard-earned reputation — or, worse, do greater harm. When a Greek TV program more than a decade ago highlighted a young boy who had been saved by Monzón's venom, Monzón told the media at the time: "Now half of the world is coming to see me. I don't want to raise people's expectations."
Indeed, every cancer expert consulted for this article, even those who have witnessed remarkable results, agrees that prudence is the best option. "It is wrong to play with the hopes of people in such desperate situations," says Di Lorenzi, the Roman doctor.
Back at his house, Leandro wears a jean jacket to protect against the Cuban winter's cool breeze. He's playing with his pet turtle. "I named her Cuca!" he says excitedly. The boy was sad to see his dog go when he became ill, but his mom was concerned that the fur and dirt might threaten her son's fragile health. Similarly, Leandro's parents keep him away from large crowds.
Yaima also prefers that he ride his bike only in the backyard. "Just until he gets better," she says, though no one knows whether he will make a full recovery. She doesn't seem bothered by the uncertainty; she began this therapy with her eyes open and knows there are no guarantees. She's just glad her son has a shot at surviving.
As a reporter and a photographer prepare to leave, the boy gives high-fives. Then he slaps the hand of the driver, whom he'll see again soon: It's the same driver in the same white van that drops off his free medicine a few times a month. Leandro thought New Times was there to take him for a visit to his physician. The miracle child can't conceive of his questionable future. But he already knows what he wants to be when he grows up: "a doctor."
https://www.miaminewtimes.com/news/blue-scorpion-venom-cubas-miracle-drug-6391741
An IND application may go into effect: 30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or. on earlier notification by FDA that the clinical investigations in the IND may begin.
After submitting IND application initially the FDA requested more information:
Medolife Rx Announces Positive Results in Clinical Safety Study on Its Polarized Drug Candidate for the Treatment of COVID-19
March 18, 2021
Medolife" a global integrated bioceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. announced today positive results in a safety and toxicity study conducted on its polarized drug candidate derived from a small molecular peptide found in scorpions, designed to treat patients with the SARS-CoV-2 virus, also known as COVID-19. The results showed no signs of toxicity in any of the patients involved in the study who were given the drug Escozine®, which is a polarized solution of the Rhopalurus princeps scorpion peptide owned by Medolife.
The study, which was conducted in Santo Domingo of the Dominican Republic under the supervision of medical principal investigators, was conducted on over 500 patients, where data from one group of patients was used in the Company’s FDA pre-IND filing. Each patient was given Escozine® sublingually four times a day. During and after administration, a complete blood count (CBC) was conducted on each patient where the researchers measured various parameters to evaluate if the drug candidate was safe, such as hemoglobin (Hb), hematocrit (HCT), and red blood cells (RBCs) levels. There were no significant differences observed before or after administration. Additionally, there were no significant differences observed in white blood cells (WBCs), neutrophils, lymphocytes, monocytes, or eosinophils, concluding that the drug candidate was safe and non-toxic.
“A successful safety study is a pivotal step in the clinical development program for a new drug candidate and we could not be more enthusiastic about our results,” said Medolife CEO Dr. Arthur Mikaelian. “While our near-term goal is to work with the Ministry of Environment of The Dominican Republic to bring this drug to market, we are able to use this data in our programs around the world, including with our submissions to the United States Food and Drug Administration. While there is significant research that suggests the potential therapeutic benefits of extracted scorpion peptide, when paired with our proprietary polarization technology that increases efficacy and bioavailability in the body, we believe our product Escozine® could be a true breakthrough in the field of medicine with applications in a variety of focus areas and indications.”
The Company is currently involved in various clinical studies on Escozine® around the world. It is seeking product registration in the Dominican Republic for treatment of COVID-19 where this study took place, while simultaneously seeking approval in the United States, where it has filed data on Escozine® with the US Food and Drug Administration (FDA) as a Pre-Investigational New Drug (PIND #150335) as a COVID-19 therapeutic. Registration in the Dominican Republic would act as a proof-of-concept on the drug that would propel it forward in its path to market.
Medolife’s patented polarization technology increases the potency of single molecules and complex compounds. This technology is already used in various Medolife products, ranging from supplements to drug candidates.
So before the 30 days were up FDA notify the need for more information and on April 13, 2021 QNTA released a PR:
Medolife Rx Submits Final Data Set to FDA for IND Filing on Lead Drug Candidate
The Company assembled detailed information regarding the manufacturing of Escozine®, clarity on dosing, as well as both previous and new safety and efficacy data derived from an on-going human study taking place in the DR. The study has been conducted on over 500 participants and intends to demonstrate the safety and efficacy of Escozine®. Escozine® is a polarized solution of the Rhopalurus princeps scorpion peptide owned by Medolife, which has been filed with the FDA under the IND regulatory pathway as well as the Ministry of Health in the DR where the Company is seeking product registration. Previous clinical data was submitted to the FDA including preliminary results of the safety study, which has now been expanded upon. This data, as well as the batch of Escozine® that was produced specifically for the FDA, has now been submitted. After the review of the data and barring any further inquiries or requests, the FDA will designate IND status for Escozine®, essentially allowing the drug to be distributed in the US. After such designation, the Company will pursue other clinical applications of Escozine®, including as a potential cancer therapeutic where the Company has already released positive clinical results.
“The FDA-approved therapeutic drug market is the gold standard globally and should we receive IND designation from the FDA, it would catapult our other research across the world,” said Medolife CEO Dr. Arthur Mikaelian. “Submission to the FDA is never easy, but we are generating such positive clinical trial results that we are confident the regulatory body will take notice. They have been reviewing our submission for some time, requesting various other information that we have now submitted. I believe this could be the last request ahead of approval, which would be tremendous not only for our Company, but for patients who are in need of a solution where one does not currently exist. An approval from the FDA would also propel interest from the scientific community on the potential therapeutic benefits of the natural peptides we are studying, including investment and partnership interest.”
The Company has conducted extensive clinical studies on Escozine® as a therapeutic for both COVID-19 and multiple forms of cancer in the US and globally. It is seeking product registration in the DR for treatment of COVID-19 through its exclusive relationship with the Ministry of Health. Escozine® utilizes a patented polarization technology developed by Dr. Mikaelian that increases the potency of single molecules and complex compounds.
https://www.otcmarkets.com/stock/QNTA/news/story?e&id=1862474
One of two things WILL HAPPEN at the end of the 30 days, the approval goes forward or we get a Press Release if FDA requires more information.
Until then the stock will probably continue to be very unstable and unpredictable and getting more stable as we move closer to the 13TH.
For anyone who wants to get a better feel for Scorpion Venom check out the video below:
https://news.yahoo.com/why-scorpion-venom-most-expensive-160636769.html#:~:text=Its%20venom%20costs%20%2439%20million,expensive%20liquid%20in%20the%20world.
News Feature: Venom back in vogue as a wellspring for drug candidates
How a new wave of research on venoms from an array of creatures could seed future pharma development.
Pediatric neurosurgeon Amy Lee works by the small, bright light of a microscope, her gaze focused on the opened skull of a child. Lee moves her hands calmly and confidently over the exposed brain, plucking out as much tumor as she safely can.
A handful of promising new drug candidates are derived from peptides in the venom of scorpions and other animals. Image credit: Shutterstock/Bens_Hikes.
But there are some surgeries, and some parts of the brain, where tumor tissue and healthy tissue look very much alike. In those cases, Lee, based at Seattle Children’s Hospital in Washington, looks to a computer monitor beside the operating table, where a view of the brain shows tumor, illuminated in fluorescent green, nestled in otherwise white, healthy tissue. This new diagnostic tool helps surgeons gauge, in real time, how much tumor they’ve removed, and how much is left behind.
Drug candidate tozuleristide, derived from scorpion venom, glows green in breast tissue removed during a lumpectomy surgery. Image credit: Blaze Bioscience.
That green glow comes from tozuleristide, a new diagnostic drug in phase two clinical trials. But the drug’s novelty stems not only from its potential to highlight troublesome childhood tumors, but also from the compound’s source: the potent venom of the Israeli deathstalker scorpion (Leiurus quinquestriatus).
Tozuleristide uses a peptide from the venom and an infrared dye to seek out and illuminate tumors of all kinds, including in the breast, colon, and skin. The drug has gone through safety testing and early clinical trials to image brain tumors in children, and today stands about two years from possible US Food and Drug Administration (FDA) approval. The key ingredient, the scorpion venom peptide chlorotoxin, is just one of many untapped, and potentially lifesaving toxins in the venom of snakes, scorpions, spiders, and other creatures, honed through millions of years of evolution to immobilize prey or fend off predators.
Now, the pharmaceutical industry has a growing interest in venom, as some companies opt to return to drug discovery inspired by natural compounds, a trend that fell out of fashion about 40 years ago. Excitement about drugs such as viper venom-inspired captopril in the early 1980s waned a few years later in favor of less complex synthetic small molecules that chemists could dream up in a lab. The industry sank billions of dollars into designing small molecules, often inspired by the molecular structure of existing medicines, but otherwise lacking biological context, “and none of it worked,” says chemical biologist Mandë Holford, who studies terebrid snail toxins at Hunter College, the American Museum of Natural History, and Weill Cornell Medicine in New York City.
“Over the last few years it has felt like there’s a push back to natural products,” adds biologist and biochemist Helena Safavi at the University of Copenhagen in Denmark. Biting, stinging organisms have had millions of years to evolve an array of toxins that act on specific physiological pathways, she notes. Often these toxins have clear potential to treat human disease. She calls them a “treasure trove for biomedical explorations.”
Yvonne Angell, the head of peptide chemistry at ChemPartner in South San Francisco, CA, also attributes the trend to advances in affordably mass-producing peptide-based drugs, and in slowing the peptide’s breakdown in the gut or bloodstream, allowing these compounds more time than ever to act as therapeutics in the body. Better tools to characterize small volumes of venoms also let researchers study never-before-investigated peptide toxins, from tiny critters such as centipedes that produce a miniscule amount of poison (1).
Slow Burn
People have used venoms as medicines for thousands of years. In India, needles dipped in snake venom feature in a fiery kind of Ayurvedic acupuncture to treat joint pain and inflammation (2, 3). In China, dried venoms from the lumpy brown skins of toads are traditional anticancer treatments (4). In Southeastern Mexico, a beverage of mashed tarantula, alcohol, and herbs traditionally treats chest pain and asthma (5). Western medicine’s interest in venom grew from traditional uses and blossomed in the early 1980s with the advent of the first venom-derived drug, captopril.
Captopril was conceived as a specific enzyme inhibitor, according to the drug’s codevelopers (6). The researchers collaborated at the Squibb Institute for Medical Research in New Brunswick, NJ, beginning in the 1960s. Captopril’s key ingredient, inspired by a peptide in the Brazilian jararaca pit viper’s venom, binds and blocks the active site of angiotensin-converting enzyme (ACE), preventing release of a peptide hormone that causes blood vessels to constrict. When taken orally, captopril lowers high blood pressure by relaxing the circulatory system, explains Glenn King, a biochemist at the University of Queensland outside Brisbane, Australia. Having studied venom toxins since 1995, he’s seen the FDA approve nine more venom-derived drugs, with the most recent approval in 2012. At least one more venom-derived drug, batroxobin, is available outside of the United States (7).
All 10 FDA-approved medications are based on venom peptides or larger proteins, the main ingredients in the cocktail of toxins delivered by a bite or sting. Peptides and proteins are stable in the body, and highly specific, often acting on just one or several kinds of membrane protein, ion channel, enzyme, or other binding site.
Take spiders, for example: They’ve had 400 million years to evolve hundreds of venom peptides, many of which act on nervous system ion channels. Some tarantula venom peptides that King is now studying selectively bind and inactivate one ion channel involved in pain signaling to paralyze their prey, by binding voltage sensors outside of the pore, which can selectively shut off the channel.
Pharmaceutical companies have tried with limited success to develop a drug inhibiting the same kind of ion channel—using drugs to block the channel’s pore, “like a cork in a wine bottle,” King says. The trouble with that approach: Pore-blocking synthetic small-molecule drugs can’t distinguish between the pores. King wanted a more selective molecule than a pore binder, and found that the tarantula venom peptides bind much more specific voltage sensors. Now, he is exploring the tarantula venom peptides as highly specific channel inhibitors that could one day be new painkillers. In a 2017 study on the venom of the giant blue bloom tarantula, King and collaborators found one such peptide, at least 40 times more selective for the pain channel than for any other channels (8). However, there’s plenty of work to be done—the same study found that the peptide may not completely inhibit the channel in vivo.
Painkillers could also come from the toxins of scorpions, wasps, bees, and ants, all of which use venoms that primarily target the nervous system. Toxins from snakes have more potential as therapeutics for heart attack and stroke, because they affect the cardiovascular system.
And one recently discovered ingredient in marine cone snail venom could offer a promising avenue for diabetes treatments. The coral reef-dwelling geographer cone has a wicked means of attack: The cone releases a cloud of insulin to incapacitate small prey fish by crashing their blood sugar. In work carried out at the University of Utah in Salt Lake City since the mid-2010s, Safavi has shown that the snail insulin acts in seconds on the human insulin receptor (9), likely because the snail’s insulin lacks a clunky hinge-like structure that other insulins require for binding. In a study published earlier this year, Safavi discovered two more fish-hunting cone snails that also have fast-acting insulins (10). Although these venoms may bring instant death to little fish, Safavi thinks they could offer fast-acting new medicines to diabetics, whose therapies typically take 15 to 90 minutes. Safavi says she and collaborators recently licensed a compound inspired by snail insulin to a small San Francisco, California-based biotech company called Monolog, which is leading the compound’s drug development in the lead-up to clinical trials.
Feeling the Heat
Despite the growing interest, only 10 drugs have received FDA approval for venoms since 1981, and the last one was more than eight years ago. “Certainly the techniques and processes are much better,” to develop venom-based drugs, King says. “So you’d think we’d be doing better, not worse.”
He sees no smoking gun, but suspects that the drug drought comes partly “because we’re going for harder things.” Many of the earliest venom-based drugs acted on enzymes in the cardiovascular system, such as clotting enzymes, he notes, which tend to have just one or several subtypes for a drug to target. Now drug development is looking to target diseases of the nervous system, which entails designing drugs that can act selectively on ion channels that can have dozens of hard-to-distinguish subtypes. Designing drugs to target such diseases in the brain is harder still, because the therapeutic compounds must cross the highly selective blood–brain barrier.
The consequences of a drug binding the wrong target are also more dangerous in the nervous system, King notes, where side effects can include paralysis or even death. Mistakes in the cardiovascular system are usually more fixable, because existing drugs can reverse excessive clotting or bleeding. This confluence of challenges has waylaid new toxin drug development.
A few drug candidate contenders could break the dry spell. Tozuleristide is one of them. So far it’s the only fluorescent brain tumor-imaging agent for kids. The drug completed phase one clinical trials in pediatric brain cancer patients in 2018, demonstrating that it’s safe to use in surgery. Neurosurgeon Lee at Seattle Children’s is now leading a phase two trial, in collaboration with surgeons at nine hospitals around the country, to determine how well tozuleristide illuminates tumor tissue rather than healthy brain.
Lee uses tozuleristide to complement her expert judgment, to cross-check how much tumor she has already removed, and how much tumor remains. If, during surgery, there’s no green glow left on the monitor beside her, “then I know I’ve gotten all of it,” Lee explains. “Or if it’s not safe to remove, we’re aware we left tumor there,” she adds. The troublesome tissue could then be treated with radiation or chemotherapy.
A few miles away from Lee’s operating room, Blaze Bioscience of Seattle, WA, is working to develop tozuleristide. President and CEO Heather Franklin estimates that the drug, if approved for pediatric brain cancer and eventually for most solid tumor cancer surgeries, could be useful to about two million patients per year in the United States and Europe.
What makes tozuleristide unique, says Blaze cofounder Jim Olson, is that its venom peptide chlorotoxin is retained in tumors and can cross the blood–brain barrier. Exactly how the toxin does this, and how it invades tumor cells—not only in the brain, but throughout the body—remains unclear. Olson, whose lab at the nearby Fred Hutchinson Cancer Research Center in Seattle created the molecular proof of concept for the drug, suspects that chlorotoxin’s tight, knot-like shape protects it from enzymes that would degrade the peptide, and may help it slip across the blood–brain barrier.
A Wide Web
Several other toxins are also snaking through clinical trials, including a drug candidate called dalazatide, inspired by the venom of the Caribbean sun sea anemone. From above, the anemone’s soft bed of yellow-green tentacles look spongy and inviting, but they pack a nasty sting, strong enough to kill little prey fish.
One component of the anemone’s sting, a peptide called ShK, shows promise to treat autoimmune diseases, including lupus, type 1 diabetes, inflammatory bowel disease, psoriasis, and multiple sclerosis (11). The peptide’s power comes from its ability to bind and block a potassium channel involved in autoimmune disorders. Blocking this channel, which is common on the surface of certain T cells, stops the cells from triggering the hallmark inflammation of autoimmune diseases, explains immunologist Michael Cahalan at the University of California, Irvine.
—Glenn King
One caveat is that ShK isn’t highly selective. It can bind and block several different kinds of potassium channels, not just the targeted one. Potential side effects in humans are unknown. “Rats injected with ShK seem perfectly fine,” Cahalan says. “They run about and sniff each other and engage in normal rat behavior.”
To get around potential side effects, Cahalan collaborated with George Chandy for more than 30 years at UC Irvine to develop dalazatide, a synthetic mimic of ShK that’s more selective, because it has an extra phosphorylated amino acid. The addition makes the peptide a little bigger, so it doesn’t bind as well to the unintended channels (12). Dalazatide is now gearing up for phase 1b clinical trials, according to the start-up TEKv Therapeutics in Columbus, OH, which is leading the dalazatide program.
And this March, a study reported that another scorpion venom-derived peptide, CDP-11R, rapidly concentrates in the cartilage of mice (13), the first venom peptide known to do so. Researchers used the peptide to selectively target cartilage to deftly deliver antiinflammatory steroids to arthritic joints. Steroids are used to treat arthritis, but they often have undesirable side effects when applied systemically. In the new study, Olson and a team from the Fred Hutchinson Cancer Research Center and Blaze Bioscience showed that a conjugate of the venom peptide and antiinflammatory steroids could much more selectively direct steroids to reverse inflammation in cartilage. The project is now poised for the preclinical safety studies, Olson says.
According to King, the pace of venom research is accelerating, and the number of candidates in the pipeline is growing. Some 220,000 animal species are known to be venomous, of which few have been studied in depth (1). New tools, such as transcriptomics, can sequence a droplet of liquid in a tiny venom gland, revealing the hundreds of peptides that an organism might use as toxins.
With ready tools revealing thousands of new peptides, “we will see an explosion of information about venoms and venomous animals in the next 10 years or so,” King predicts. Whether those venoms will contain peptides that treat major diseases is more difficult to divine.
But even if the venoms themselves are not medicinal, understanding which receptors they hit in the body could offer new treatment targets, he adds. The itchy, stinging hairs of the Amazonian Pararama caterpillar, for instance, contain a toxin that temporarily causes pain, swelling, and other arthritis-like symptoms that can eventually damage cartilage and joints (14). Researchers at Brazil’s biomedical Instituto Butantan in São Paulo are now studying the toxins in the hairs to identify new molecules the caterpillar uses to induce inflammation. Identifying the molecules involved may point to new antiinflammatory drug targets for arthritis treatments. The question in that case, King says, is not “what are the venom molecules, but what are they hitting?”
Whether the venom drug drought ends with candidates like tozuleristide, the field of venom drug development is starting a new chapter. “We’re going to find new molecules,” King says. But he sounds a cautious note. “It will be a long time until we understand the function of those molecules, and whether any of them might be therapeutically useful.”
https://www.pnas.org/content/117/19/10100
Scorpion venom is currently in active research by large pharmaceutical companies for its therapeutic use in treating cancer, COVID-19, viral diseases, inflammation, and pain, all of which are independently multi-billion-dollar industries.
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Why scorpion venom is the most expensive liquid in the world
April 16, 2021
The deathstalker is one of the most dangerous scorpions on the planet. Its venom costs $39 million per gallon, making it the most expensive liquid in the world.
Medolife should be good-to-go with its application for an IND.
The IND application must contain information in three broad areas:
Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).
Manufacturing Information - Information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators--professionals (generally physicians) who oversee the administration of the experimental compound--to assess whether they are qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
The information below suggests that Medolife have already met or exceeded FDA requirements for an IND.
Medolife's Therapeutic Scorpion Peptide Proves Successful in Treating COVID-19 Patients in Dominican Republic Study
January 27, 2021
Medolife" a majority owned subsidiary of Quanta, Inc. today announced In a recent study, a total of 400 patients in the Dominican Republic - where, a majority tested positive for COVID-19, and a small portion were COVID-19 symptomatic even though they tested negative for COVID-19 - reported a 100 percent improvement in symptoms after being administered Escozine®. Many of the patients participating in the study reported severe COVID-19 symptoms, such as difficulty breathing, pain and high fever, which Escozine® was able to relieve within 5 days of treatment. Even patients under ventilators were discharged within days, thanks to this novel product. Located in Santo Domingo, Dominican Republic, The Cruz Jiminian Clinic has carried out this ongoing study since August 2020, and has reported 0 COVID-19 related deaths after the clinic began administering Escozine®. Escozine®, produced by Medolife Rx, Inc., ("Medolife"), is a therapeutic consisting of small molecule peptides derived from a specific species of scorpions, Rhopalurus princeps, endemic to the Dominican Republic. After the successful study, Escozine® is on fast-track to be registered with the Ministry of Health in the Dominican Republic in Q1 2021. Medolife also submitted the study data to the US FDA, which is currently under review for permission to repeat the clinical trial in the United States. In addition to supporting the recovery of COVID-19 patients, Escozine® was registered and certified for cancer treatment by the Ministry of Health in the Dominican Republic in 2010.
"The data proving the efficacy that Escozine has on a multitude of improved patient parameters is consistent with the rapid symptom relief I experienced while on site," said Dr. Annabelle Morgan, Cell and Developmental Biologist and one of Medolife's leading scientists. She noted, "What is even more astonishing is that 100% of patients tested negative for COVID-19 within 5-10 days of treatment."
"More importantly, all COVID-19 healthcare workers, including physicians and nurses, who took Escozine as a preventative, never tested positive" said Dr. Khalid Matalka, another leading scientist at Medolife, specializing in Cancer Therapy and Immunology. "The clinical trial results indicate that Escozine could be used as monotherapy or in combination with standard therapies against COVID-19, which will accelerate the healing from the virus. Besides, observations revealed that Escozine could be used as prevention from the COVID-19 infection."
Scorpion Venom Most Expensive Liquid in the World
From treating cancer to pain management to fighting viral infections, this unique peptide has a vast range of therapeutic applications. In the last decade, a growing interest from Big Pharma companies has caused an increase in the liquid's value: costing $39 million per gallon.
Medolife's Dominican Republic Scorpion Reservation is one of the largest breeding grounds for scorpions on earth. Combined with the company's more than 15 years of research, Medolife is positioned to continue developing groundbreaking formulas and pharmaceutical-grade medications for consumer use.
Medolife Rx Announces Positive Results in Clinical Safety Study on Its Polarized Drug Candidate for the Treatment of COVID-19
Medolife" a global integrated bioceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. announced today positive results in a safety and toxicity study conducted on its polarized drug candidate derived from a small molecular peptide found in scorpions, designed to treat patients with the SARS-CoV-2 virus, also known as COVID-19. The results showed no signs of toxicity in any of the patients involved in the study who were given the drug Escozine®, which is a polarized solution of the Rhopalurus princeps scorpion peptide owned by Medolife.
The study, which was conducted in Santo Domingo of the Dominican Republic under the supervision of medical principal investigators, was conducted on over 500 patients, where data from one group of patients was used in the Company’s FDA pre-IND filing. Each patient was given Escozine® sublingually four times a day. During and after administration, a complete blood count (CBC) was conducted on each patient where the researchers measured various parameters to evaluate if the drug candidate was safe, such as hemoglobin (Hb), hematocrit (HCT), and red blood cells (RBCs) levels. There were no significant differences observed before or after administration. Additionally, there were no significant differences observed in white blood cells (WBCs), neutrophils, lymphocytes, monocytes, or eosinophils, concluding that the drug candidate was safe and non-toxic.
“A successful safety study is a pivotal step in the clinical development program for a new drug candidate and we could not be more enthusiastic about our results,” said Medolife CEO Dr. Arthur Mikaelian. “While our near-term goal is to work with the Ministry of Environment of The Dominican Republic to bring this drug to market, we are able to use this data in our programs around the world, including with our submissions to the United States Food and Drug Administration. While there is significant research that suggests the potential therapeutic benefits of extracted scorpion peptide, when paired with our proprietary polarization technology that increases efficacy and bioavailability in the body, we believe our product Escozine® could be a true breakthrough in the field of medicine with applications in a variety of focus areas and indications.”
The Company is currently involved in various clinical studies on Escozine® around the world. It is seeking product registration in the Dominican Republic for treatment of COVID-19 where this study took place, while simultaneously seeking approval in the United States, where it has filed data on Escozine® with the US Food and Drug Administration (FDA) as a Pre-Investigational New Drug (PIND #150335) as a COVID-19 therapeutic. Registration in the Dominican Republic would act as a proof-of-concept on the drug that would propel it forward in its path to market.
Medolife’s patented polarization technology increases the potency of single molecules and complex compounds. This technology is already used in various Medolife products, ranging from supplements to drug candidates.
Medolife Rx Submits Final Data Set to FDA for IND Filing on Lead Drug Candidate
April 13, 2021
The Company assembled detailed information regarding the manufacturing of Escozine®, clarity on dosing, as well as both previous and new safety and efficacy data derived from an on-going human study taking place in the DR. The study has been conducted on over 500 participants and intends to demonstrate the safety and efficacy of Escozine®. Escozine® is a polarized solution of the Rhopalurus princeps scorpion peptide owned by Medolife, which has been filed with the FDA under the IND regulatory pathway as well as the Ministry of Health in the DR where the Company is seeking product registration. Previous clinical data was submitted to the FDA including preliminary results of the safety study, which has now been expanded upon. This data, as well as the batch of Escozine® that was produced specifically for the FDA, has now been submitted. After the review of the data and barring any further inquiries or requests, the FDA will designate IND status for Escozine®, essentially allowing the drug to be distributed in the US. After such designation, the Company will pursue other clinical applications of Escozine®, including as a potential cancer therapeutic where the Company has already released positive clinical results.
“The FDA-approved therapeutic drug market is the gold standard globally and should we receive IND designation from the FDA, it would catapult our other research across the world,” said Medolife CEO Dr. Arthur Mikaelian. “Submission to the FDA is never easy, but we are generating such positive clinical trial results that we are confident the regulatory body will take notice. They have been reviewing our submission for some time, requesting various other information that we have now submitted. I believe this could be the last request ahead of approval, which would be tremendous not only for our Company, but for patients who are in need of a solution where one does not currently exist. An approval from the FDA would also propel interest from the scientific community on the potential therapeutic benefits of the natural peptides we are studying, including investment and partnership interest.”
The Company has conducted extensive clinical studies on Escozine® as a therapeutic for both COVID-19 and multiple forms of cancer in the US and globally. It is seeking product registration in the DR for treatment of COVID-19 through its exclusive relationship with the Ministry of Health. Escozine® utilizes a patented polarization technology developed by Dr. Mikaelian that increases the potency of single molecules and complex compounds.
https://www.otcmarkets.com/stock/QNTA/news/story?e&id=1862474
IND Application Procedures: Overview
When submitting original IND applications, sponsors are expected to send their applications in triplicate (one original and two copies). Electronic submissions should be considered whenever possible (FDA Study Data Standards Resources).
Each application should be accompanied by:
Form 1571 (PDF - 830KB) (IND application cover),
Form 1572 (PDF - 718KB) (Investigator’s statement), and
Form 3674 (PDF - 3MB) (certification requirement & mandatory registration and reporting of results for applicable clinical trials through ClinicalTrials.gov.)
While IND application sponsors are not required to submit information regarding clinical investigators’ financial interests or arrangements in the original IND applications, they are expected to collect this information before a clinical investigator participates in a clinical study. For further information refer to Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators (PDF - 165KB).
The current address for sending IND applications may be found at Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs).
Upon receipt of an IND application, FDA will notify the sponsor of the date it receives the application through an IND acknowledgment letter.
An IND application may go into effect:
30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or
on earlier notification by FDA that the clinical investigations in the IND may begin.
Once an IND application is in effect, a drug manufacturer may ship the investigational new drug to the investigator(s) named in the application. An investigator may not administer an investigational new drug to human subjects until the IND application goes into effect.
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