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Whether a stock is on the OTC pink, OTCQB or even the NASDAQ, it will take solid catalysts to move the stock price.
Sales of goods or making progress through the FDA IND application process are the biggest catalysts that will launch the stock price.
Quanta POTENTIAL is HUGE and when the right catalysts are achieved it will be reflected in the stock price.
The DNA study I believe will come sooner than later however I have know idea how long the Pharmacokinetic (PK) study will take.
Pharmacokinetics (PK) Study: Drug Concentration vs. Time in the Body
A pharmacokinetic study provides the basis for determining drug exposures in the body over time. PK parameters are used in the evaluation of the absorption, distribution, metabolism, and excretion (ADME) processes of drugs.
Absorption
Absorption, the first topic of PK studies, is the initial process by which drugs enter the blood circulation following dosing. Drug substances in PK lab testing can be administered to the body through several routes such as oral, nasal, dermal, or parenteral. Absorption at the gastrointestinal tract, one of the most common drug absorption sites, is affected by several factors including physicochemical parameters of the drug, gastrointestinal motility, drug concentration, and ionization state at the site of absorption.
Distribution
Distribution is a reversible drug transfer within the body from one location to another. The distribution of a drug can be influenced by several factors such as lipid-solubility, concentration in plasma and various tissues, and protein binding of drugs in plasma and tissues. PK studies assess whether compounds can distribute throughout the body readily or are confined to the bloodstream once absorbed.
Metabolism
Metabolism, an essential topic of PK analysis, is the process by which a drug is converted to another chemical entity (metabolite). Metabolism happens primarily in the liver and is classified into two broad categories: Oxidative metabolism includes hydrolysis, oxidation, and reduction reactions driven mainly by the cytochrome P450s, monooxygenase systems, and alcohol dehydrogenases. The typical chemical reactions involved in oxidative metabolism include aromatic hydroxylation, aliphatic hydroxylation, oxidative N dealkylation, oxidative O-dealkylation, S-oxidation, reduction, methylation, and hydrolysis. Most often, these reactions increase compound polarity to make a drug more soluble, facilitating elimination through the kidneys. In conjugative metabolism, conjugation occurs by glucuronidation, sulfation, amino acid conjugation, acetylation, or glutathione conjugation to aid elimination. Enzymes involved in conjugation include UDP glucoronyl transferases, aryl sulfatases, N-acetyl transferases, and glutathione S-transferases. Conjugation can serve to inactivate a compound or make it more readily eliminated by urinary or biliary excretion. Several factors influence a drug’s rate of metabolism, including the route of administration, dose, genetics, disease state, and metabolic activity.
Excretion
Eliminating the drug and other toxic substances from the body, the last topic of the PK study, is known as the process of excretion. Most drugs in the body are eliminated through the urine. Excretion also depends on the solubility of the drug in water. More soluble drugs are excreted faster in the urine. If the excretion is incomplete, the accumulation of compounds in the body can lead to adverse events. Pharmacokinetics study testing should incorporate sufficient sampling times during compound elimination for appropriate assessments of parameters such as elimination half-life and clearance.
A typical PK study in mice involves two drug delivery routes (e.g. PO and IV), 6 time points for each route (for example: 5, 15, 30, 60, 120, 240 min for IV and 15, 30, 60, 120, 240 and 360 min for PO) and 4 animals per each time point group/route, plus the common control plasma of Vehicle dosed group, 50 animals in total. We will prepare blood plasma samples and measure compound concentrations by LC-MS/MS using AB Sciex API4000/3000 mass spectrometers and Shimadzu (Prominence, VP) HPLC systems.
Medolife Rx Announces Successful Stability Results on Escozine Conjugated With Radioactive Iodine
Published: Jul 01, 2021
BURBANK, Calif., July 01, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire – Medolife Rx, Inc. ("Medolife"), a global integrated biopharmaceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. (OTC PINK: QNTA), announced today that the Company has completed a stability study on its lead drug candidate Escozine® that was conjugated with radioactive iodine, showing strong stability throughout the study. The preclinical study took place in preparation for next steps of the Company’s clinical trials on Escozine® under the guidelines of the US Food and Drug Administration (FDA).
The Company performed this preclinical study in advance of its impending Pharmacokinetic (PK) study on Escozine®, the next step outlined by the FDA in its response to the Company regarding its Pre-IND submission as a COVID-19 drug. PK studies are designed to measure the body’s intake and clearing of active pharmaceutical ingredients (APIs), which in Medolife’s case is the polarized scorpion venom peptide in Escozine®. An important mechanism of action of the peptide is that it binds only to cancer cells, leaving healthy cells untouched. The peptide in Escozine® can also pass the blood-brain barrier, which allows the compound to bind with some of the deadliest types of cancers, such as glioblastomas (brain tumors). Conjugation of Escozine® with radioactive iodine allows for researchers to more clearly see where and how Escozine® is absorbed and processed in the body. Many APIs do not remain stable when conjugated with radioactive iodine, eliminating the possibility of certain types of PK studies. However, through this preclinical study, Medolife has proven the stability of Escozine® paired with radioactive iodine and is prepared to move into a full PK study per the guidelines given by the FDA.
“Beyond our successful stability result on Escozine’s peptide conjugated with radioactive iodine, we were even more excited by its potential applications in the field of diagnostics,” said Medolife CEO Dr. Arthur Mikaelian. “We hope that those who follow our company see how quickly we are moving in this process since receiving our response from the FDA. These programs generally take years and we have wasted no time since receiving the guidelines in preparing for our next steps. We are extremely confident in Escozine’s potential palliative and therapeutic benefits and look forward to updating those interested as soon as possible.”
The Company recently announced that it has received a detailed response from the FDA on its Pre-Investigational New Drug (Pre-IND) submission on Escozine® as both a potential palliative and therapeutic drug for the SARS-CoV-2 (COVID-19) virus. In the response, the FDA acknowledged the Company’s clinical trial that took place in the Dominican Republic (DR) as a proof-of-concept study and provided detailed guidelines for next steps in its approval process. Among those were the request to perform further toxicology studies on Escozine®, including a DNA toxicology study, as well as the predetermined next step of performing a PK study, which is extremely standard in clinical programs. This preclinical result enables the Company to move forward with the PK study in an expedited and efficient manner.
In addition to its usefulness in PK studies, the Company foresees additional applications for Escozine®’s peptide conjugated with radioactive iodine in the field of diagnostics. Given that the pair remains stable in the body, Escozine® conjugated with radioactive iodine could allow physicians and researchers further visualization of abnormalities in the body not previously visible without the radioactivity. Many lesions in the body can be small and difficult to identify using standard MRI imaging, but if Escozine® conjugated with radioactive iodine were introduced into the body it would be drawn to the lesions, illuminating them on imaging devices and making it easier for physicians to identify and target hard-to-see abnormalities, which could lead to a reduced recurrence of cancer. The Company plans to further investigate this hypothesis as yet another potential for Escozine® as a medical innovation and disruptor.
Best guess estimate would be 2 to 4 weeks (Prep,Test, Report) based on previous study conducted by the company:
Medolife Rx Announces Preclinical Trial Results From Toxicity Study on Lead Drug Candidate
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.
The company has been tasked with measuring toxicology at DNA level:
Subsequent to the acknowledgement of the trial, the FDA has requested that the Company complete two additional toxicology studies in animals. Since adoption of COVID-19 vaccinations, the FDA altered its protocol for measuring toxicology to include studying it at the DNA level. As this is a newer development, the agency has asked Medolife to provide data in this regard. Medolife has the product and protocol necessary to complete these studies in short-order.
I have not found any information on this particular testing protocol (DNA)to suggest a time frame however I did find this on the FDA website:
The US FDA's Coronavirus Treatment Acceleration Program ...
Overview of Non-Clinical Safety Assessment for Antiviral Drugs and Vaccines Development
• To Open an IND for Small Molecule Drugs
A battery of nonclinical studies to support a first-in-human (FIH) trial should include:
- STANDARD SAFETY PHARMACOLOGY STUDIES (e.g., cardiovascular, respiratory, and central nervous system assessments) but can be incorporated into general toxicology studies
- GENERAL TOXICOLOGY STUDIES in two species (at least one nonrodent)
- GENETIC TOXICOLOGY, including an Ames reverse mutation assay and a second in vitro assessment
What is Ames reverse mutation assay?
The Ames Salmonella/microsome mutagenicity assay (Salmonella test; Ames test) is a short-term bacterial reverse mutation assay specifically designed to detect a wide range of chemical substances that can produce genetic damage that leads to gene mutations. The test employs several histidine dependent Salmonella strains each carrying different mutations in various genes in the histidine operon. These mutations act as hot spots for mutagens that cause DNA damage via different mechanisms. When the Salmonella tester strains are grown on a minimal media agar plate containing a trace of histidine, only those bacteria that revert to histidine independence (his(+)) are able to form colonies. The number of spontaneously induced revertant colonies per plate is relatively constant. However, when a mutagen is added to the plate, the number of revertant colonies per plate is increased, usually in a dose-related manner. The Ames test is used world-wide as an initial screen to determine the mutagenic potential of new chemicals and drugs. The test is also used for submission of data to regulatory agencies for registration or acceptance of many chemicals, including drugs and biocides. International guidelines have been developed for use by corporations and testing laboratories to ensure uniformity of testing procedures. This review provides historical aspects of how the Ames was developed and detailed procedures for performing the test, including the design and interpretation of results.
What does the Ames test determine?
The Ames test is a rapid and reliable bacterial assay used to evaluate a chemical's potential genotoxicity by measuring its ability to induce reverse mutations at selected loci of several bacterial strains.
What is the purpose of the Ames assay?
The Ames test is a widely employed method that uses bacteria to test whether a given chemical can cause mutations in the DNA of the test organism. More formally, it is a biological assay to assess the mutagenic potential of chemical compounds.
What is the main advantage of the Ames test for mutation detection?
The Ames test has several key advantages: It is an easy and inexpensive bacterial assay for determining the mutagenicity of any chemical. Results are robust, and the Ames test can detect suitable mutants in large populations of bacteria with high sensitivity. It does not require any special equipment or instrumentation.Mar 22, 2021
How long does the Ames test take?
The plate is incubated for 48 hours. The mutagenicity of a substance is proportional to the number of colonies observed.
That being said, the testing will move the IND application forward and possibly approved if no further information is required.
FDA Accepts COVID-19 Clinical Study and Advises on Next Steps for Pre-IND Filing by Medolife Rx
JUNE 23, 2021
Subsequent to the acknowledgement of the trial, the FDA has requested that the Company complete two additional toxicology studies in animals. Since adoption of COVID-19 vaccinations, the FDA altered its protocol for measuring toxicology to include studying it at the DNA level. As this is a newer development, the agency has asked Medolife to provide data in this regard. Medolife has the product and protocol necessary to complete these studies in short-order.
Medolife Rx Announces Preclinical Trial Results From Toxicity Study on Lead Drug Candidate
MARCH 09, 2021
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.
The US FDA's Coronavirus Treatment Acceleration Program ...
Overview of Non-Clinical Safety Assessment for Antiviral Drugs and Vaccines Development
May 26, 2021
• To Open an IND for Small Molecule Drugs
A battery of nonclinical studies to support a first-in-human (FIH) trial should include:
- STANDARD SAFETY PHARMACOLOGY STUDIES (e.g., cardiovascular, respiratory, and central nervous system assessments) but can be incorporated into general toxicology studies
- GENERAL TOXICOLOGY STUDIES in two species (at least one nonrodent)
- GENETIC TOXICOLOGY, including an Ames reverse mutation assay and a second in vitro assessment
- The drug substance used in the toxicology studies should be identical to that proposed for clinical investigation.”
https://www.toxicology.org/groups/sig/ATA/docs/AACT_ATA_2021_Spring_Webinar.pdf
Medofile Rx will get the exposure once the word get out.
Too unbelievable to be true:
Scorpion Venom
No way people will say
Then they see the Scientific data
Then the chatter starts
Have you heard about the Scorpion Venom drug for Covid
Because it is so unusual it will and I GUARANTEE get National Exposure.
I expect once Medofile Rx get clearance from the FDA it will at some point be the talk of the town.
In 2013 Medofile RX got some press that was good and skeptical:
https://abcnews.go.com/Health/scorpion-venom-cure-ails/story?id=20755012
In 2021 Medofile Rx will get some press that is good and backed by SCIENTIFIC FACTS.
BOOM Time Coming!!!
Scorpion Venom solutions as well as Medofile Rx is virtually unknown and unbelievable in the medical world and the investment community.
In the days and weeks ahead that will change and pick up pace.
Follow the Science.
They have to release news as it is significant.
The stock price will be fine.
Medofile Rx is taking care of business and it will be reflected in the stock price.
These day to day fluctuations means nothing other than to flippers.
I mentioned Scorpion Venom to my Doctor last week and he asked:
Was the company looking for investors?
I said no, they have an IND app in place.
He wanted to know about if there were clinical trials/peer reviews.
I told him there were few.
Scorpion Venom use in the medical arena is not totally new however has been very limited.
Medofile RX is going to take it mainstream.
Certainly people including doctors/scientists are skeptical and rightly so however with clinical trials now being conducted and HARD data available for peer review the skeptics will become fewer and farther between.
This is a ground floor opportunity with a low float and very unique technology.
Follow the Science
Medofile Rx is on track to disrupt the landscape of traditional solutions to medical treatments.
The IND approval of the Covid 19 treatment by the FDA will lay the foundation for Medofile Rx to pursue its other initiatives especially solutions for cancer treatments.
IND Process
Pre-IND
Phase I
Phase II
Phase III
Product License
Phase IV
It will not take no longer than any other Toxicology test.
The company itself said it would be done in SHORT ORDER!!!
It is not a ridiculous request as it probably has to do with the way the vaccines were produce using mRNA.
Results from first Toxicology test:
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.https://ir.quantrx.com/news-events/press-releases/detail/50/medolife-rx-announces-preclinical-trial-results-from
The test only took a few weeks and was done by a CRO.
I suspect this next test will be done by a CRO and should be done and complete by the end of July if not sooner.
Medolife Rx will have a huge impact on pharmaceutical competition down the road when they successfully bring their cancer treatments through clinical trials in the USA.
Medolife Rx Announces Positive Pre-Clinical Results Showing Up to 95 Percent Cancer Cell Apoptosis with Introduction of Lead Cancer Drug Candidate
https://ir.quantrx.com/news-events/press-releases/detail/58/medolife-rx-announces-positive-pre-clinical-results-showing
Medolife Rx’s Lead Drug Candidate Escozine® Recommended by Doctor for Use in Cancer Treatment Regimen in Dominican Republic
https://ir.quantrx.com/news-events/press-releases/detail/56/medolife-rxs-lead-drug-candidate-escozine-recommended
Medolife Rx Announces Pre-Clinical Results on Escozine Showing Synergistic Effect in Killing Cancer Cells When Combined With Chemotherapy Agents
https://ir.quantrx.com/news-events/press-releases/detail/62/medolife-rx-announces-pre-clinical-results-on-escozine
Medolife Rx Announces Pre-Clinical Results on Drug Candidate Escozine Showing Efficacy in Eliminating Cell Lines in Ovarian and Bladder Cancer
https://ir.quantrx.com/news-events/press-releases/detail/53/medolife-rx-announces-pre-clinical-results-on-drug
Supply will not be a problem:
Medolife Rx Breaks Ground on Lab Facility and Increases Scorpion Count at First-of-Its-Kind Reservation in the Dominican Republic
The first-of-its-kind reservation is located in a remote area of the DR and is the ideal climate and terrain to support the healthy cultivation of various scorpions. Certain peptides found in scorpions are used in the formulation of many of the Company’s pharmaceutical and nutraceutical products. The facility, which is currently under construction on the reservation, will be approximately 250 square meters and is expandable as needed in order to meet any increases in demand. It will serve as the Company’s cGMP- and ISO-certified research lab where it will extract the peptides and conduct ongoing research and development on the clinical and wellness applications of Escozine® and other formulations. Its addition will decrease the cost of venom production, enabling the Company to lower the final cost of its products, which will increase margins and the marketability of the products. This expansion will increase the reservation’s capacity ten-fold and the Company’s goal is to be able to produce one million doses of Escozine® per month in the near term.
Any possible therapeutic that have met FDA criteria for an IND should not be held back when people are continuing to get Covid.
They would have some serious explaining to do and would probably face criminal charges.
Big Pharma is not afraid of Medofile Rx or any other company. Big Pharma is probably trying to get to the front of the line to be a PARTNER.
Absolutely true that Escozine and Escozul have been around for 10+ years.
However there were little or no clinical trials or peer reviews.
Clinical trials and peer reviews are a necessity and a game changer in the USA.
Also when FDA approval comes down the insurance companies will eventually pick up the costs.
Supply will not be a problem:
Medolife Rx Breaks Ground on Lab Facility and Increases Scorpion Count at First-of-Its-Kind Reservation in the Dominican Republic
The first-of-its-kind reservation is located in a remote area of the DR and is the ideal climate and terrain to support the healthy cultivation of various scorpions. Certain peptides found in scorpions are used in the formulation of many of the Company’s pharmaceutical and nutraceutical products. The facility, which is currently under construction on the reservation, will be approximately 250 square meters and is expandable as needed in order to meet any increases in demand. It will serve as the Company’s cGMP- and ISO-certified research lab where it will extract the peptides and conduct ongoing research and development on the clinical and wellness applications of Escozine® and other formulations. Its addition will decrease the cost of venom production, enabling the Company to lower the final cost of its products, which will increase margins and the marketability of the products. This expansion will increase the reservation’s capacity ten-fold and the Company’s goal is to be able to produce one million doses of Escozine® per month in the near term.
Big Pharma will line up to partner/license our products.
There is a lot of work to be done and we will need plenty of partners.
Medofile RX is probable for IND approval.
The buying will come after approval and it won't be a nickle.
The FDA (CDER) must do their due diligence before giving the GREEN LIGHT
The day and time is unknown however each day passing is a day closer.
Medofile Rx has the technology to outperform what VRML did back in 2009-2010 after getting FDA approval for a Ovarian cancer test.
Here is a message from this EPIC rise:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=41400873Sep 14, 2009 2.00 4.79 1.99 3.08 2,819,800 3.08
Date Open High Low Close Volume Adj Close*
Mar 3, 2010 30.00 31.56 29.05 31.50 141,600 31.50
Mar 2, 2010 31.25 31.43 29.50 30.20 113,000 30.20
Mar 1, 2010 32.00 32.70 30.55 31.43 157,700 31.43
Feb 26, 2010 31.00 32.24 31.00 32.03 133,900 32.03
Feb 25, 2010 30.20 31.25 29.05 31.00 124,300 31.00
Feb 24, 2010 28.70 30.25 28.60 30.00 194,000 30.00
Nov 13, 2009 22.70 23.53 22.30 23.20 328,900 23.20
Nov 12, 2009 19.25 23.70 18.80 22.20 896,300 22.20
Nov 11, 2009 18.00 18.95 17.75 18.75 36,000 18.75
Nov 10, 2009 18.60 19.00 17.75 18.25 48,200 18.25
Nov 9, 2009 17.40 19.20 17.40 18.75 119,100 18.75
Oct 14, 2009 15.10 16.00 15.10 15.80 297,400 15.80
Oct 13, 2009 14.65 15.79 13.26 15.25 150,500 15.25
Oct 12, 2009 10.26 14.75 10.25 14.65 396,900 14.65
Oct 9, 2009 11.25 12.00 9.56 10.26 604,600 10.26
Oct 8, 2009 14.80 15.25 12.50 12.50 219,200 12.50
Sep 14, 2009 2.00 4.79 1.99 3.08 2,819,800 3.08
Sep 11, 2009 0.05 1.29 0.05 1.29 1,942,500 1.29
Sep 10, 2009 0.05 0.05 0.05 0.05 1,700 0.05
Sep 9, 2009 0.05 0.05 0.04 0.05 1,700 0.05
Sep 8, 2009 0.04 0.04 0.04 0.04 18,500 0.04
Basically the FDA news sent the stock flying starting September 11, 2009 and it rose steadily until March 2010. It did hit the $20 range and October before retreating back to the teens and from there it did a steady rise to the $30 range by March 2010. With pull backs and consolidations along the way. The interesting part is the MMs did a wonderful job keeping a handle on this epic rise.
I believe Medofil Rx Future EPIC rise will GREATLY over shadow VRML’s rise.
Why?
Escozine and its many many solutions:
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 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."
Medolife has completed extensive pre-clinical and clinical research on Escozine® as a potential therapeutic for various types of cancer. After observing the research and reviewing the data, the esteemed doctor made a formal recommendation to begin use of Escozine® in cancer therapies. He came to the conclusion, as noted in his formal recommendation, after making clinical observations that patients who used Escozine® as a part of their cancer therapeutics regimen saw:
- Improvements in their quality of life
- Decreased intensity of pain in affected areas
- Decreases in the diameter of tumor masses
- Improvement in their sleep conditions
- Prolonged life span
- No observed side effects
The doctor also endorsed further clinical investigations on Escozine® as a cancer therapeutic, which Medolife is currently conducting in both the United States and the Dominican Republic. It recently announced pre-clinical results on Escozine’s efficacy in eliminating cell lines in ovarian and bladder cancer whereas it eradicated the cell lines completely, creating a path forward for Escozine® as a cancer-fighting drug, along with its life-improvement benefits.
Medolife RX is awaiting FDA approval.
Developing New Drugs
American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA's Center for Drug Evaluation and Research (CDER).
The center's best-known job is to evaluate new drugs before they can be sold. CDER's evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.
Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.
Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.
FDA Approval: What it means
FDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. The drug approval process takes place within a structured framework that includes:
Analysis of the target condition and available treatments—
FDA reviewers analyze the condition or illness for which the drug is intended and evaluate the current treatment landscape, which provide the context for weighing the drug’s risks and benefits. For example, a drug intended to treat patients with a life-threatening disease for which no other therapy exists may be considered to have benefits that outweigh the risks even if those risks would be considered unacceptable for a condition that is not life threatening.
Assessment of benefits and risks from clinical data—FDA reviewers evaluate clinical benefit and risk information submitted by the drug maker, taking into account any uncertainties that may result from imperfect or incomplete data. Generally, the agency expects that the drug maker will submit results from two well-designed clinical trials, to be sure that the findings from the first trial are not the result of chance or bias. In certain cases, especially if the disease is rare and multiple trials may not be feasible, convincing evidence from one clinical trial may be enough. Evidence that the drug will benefit the target population should outweigh any risks and uncertainties.
Strategies for managing risks—All drugs have risks. Risk management strategies include an FDA-approved drug label, which clearly describes the drug’s benefits and risks, and how the risks can be detected and managed. Sometimes, more effort is needed to manage risks. In these cases, a drug maker may need to implement a Risk Management and Mitigation Strategy (REMS).
Although many of the FDA’s risk-benefit assessments and decisions are straightforward, sometimes the benefits and risks are uncertain and may be difficult to interpret or predict. The agency and the drug maker may reach different conclusions after analyzing the same data, or there may be differences of opinion among members of the FDA’s review team. As a science-led organization, FDA uses the best scientific and technological information available to make decisions through a deliberative process.
Accelerated Approval
In some cases, the approval of a new drug is expedited. Accelerated Approval can be applied to promising therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies. This approach allows for the approval of a drug that demonstrates an effect on a “surrogate endpoint” that is reasonably likely to predict clinical benefit, or on a clinical endpoint that occurs earlier but may not be as robust as the standard endpoint used for approval. This approval pathway is especially useful when the drug is meant to treat a disease whose course is long, and an extended period of time is needed to measure its effect. After the drug enters the market, the drug maker is required to conduct post-marketing clinical trials to verify and describe the drug’s benefit. If further trials fail to verify the predicted clinical benefit, FDA may withdraw approval.
Since the Accelerated Approval pathway was established in 1992, many drugs that treat life-threatening diseases have successfully been brought to market this way and have made a significant impact on disease course. For example, many antiretroviral drugs used to treat HIV/AIDS entered the market via accelerated approval, and subsequently altered the treatment paradigm. A number of targeted cancer-fighting drugs also have come onto the market through this pathway.
How long does it take the FDA to approve a new drug?
Priority Review: During Priority Review, the FDA takes action on a new drug application within six months, compared to 10 months under standard review. These drugs receive higher priority because they can significantly improve the treatment, diagnosis, or prevention of serious conditions.Apr 13, 2020
How is drug evaluated before it is approved in the market?
A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.
They are nodding their heads in ASTONISHMENT
Why?
Medolife's Therapeutic Scorpion Peptide Proves Successful in Treating COVID-19 Patients in Dominican Republic Study
"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."
https://ir.quantrx.com/news-events/press-releases/detail/46/medolifes-therapeutic-scorpion-peptide-proves-successful
Dr. Annabelle Morgan:
Nowadays, we don’t always equate science with healing. Science can save our lives (the greatest innovations have occurred inside of science labs), but it can also be driven by big business and controlled by government regulations. The story you are about to hear is one of scientific innovation, brilliant healing power, and how the two merged together. Welcome to the podcast, our first ever woman scientist, Dr. Annabelle Morgan! Dr. Annabelle has a PhD in Cell and Developmental Biology; she’s a mother of 4, and wife to Grammy Award winning reggae artist, Gramps Morgan. Dr. Annabelle is a cancer researcher, a consultant to both medical science businesses and government, and most importantly, a mother who took her science chops and her powerful intuition, and used it to cure her son of tragic brain-related injury using hemp-derived compounds that she herself made. Now, she works to merge science and the natural space through implementing cannabis and/or plant compounds in general into current modern medicine. More recently Dr. Annabelle has been pulled into some potential research for co-vid 19 treatment (you’ll hear more about that later in the episode).
Dr.Annabelle is also on the advisory board for our podcast sponsor Quanta! Quanta is an applied science company, focused on enhancing energy levels in plant matter (including cannabis) to increase performance within the human body.
This episode is sponsored by Quanta, an applied science company, focused on enhancing energy levels in plant matter (including cannabis) to increase performance within the human body. It is sold in hundreds of doctor’s offices, pharmacies and gyms and spas throughout the country. Their patented technology is proven to supercharge key ingredients and make them perform 5 times for effectively within the human body. It is optimized to drastically reduce both pain and inflammation naturally.
If anyone has not listen to Dr. Annabelle Morgan on the podcast below please do so. What she did to help her son is amazing!
What is more AMAZING is she is part of the Medofile Rx team.
AMAZING simply AMAZING
https://goingbeyondmovement.com/podcast/the-healing-side-of-science-with-scientist-dr-annabelle-morgan/
The Vaccines work.
People who are not vaccinated are at a higher risk with the Delta Variant spreading.
But it's still unclear whether Delta will go the mostly harmless way of other variants – or pose a serious threat to people who choose to skip COVID-19 shots.
"Globally, Delta is the most serious development that we know of in terms of the evolution of the virus," said William Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health.
The real danger, if any, will be to people who have chosen not to get vaccinated, he and others said.
"Until a few weeks ago, I would have said they're probably going to get away with (being unvaccinated)," said Dr. Robert Wachter, chair of the Department of Medicine at the University of California, San Francisco. But "if Delta really takes off, that choice looks worse and worse."
Vaccinated people should remain safe, he and others said. Even if they do get infected, they're likely to get a mild case of COVID-19.
But Wachter said a few new facts have made him worried about Delta's impact on unvaccinated Americans.
First, he's now convinced that Delta will take over as the main cause of COVID-19 in the U.S. because it's more contagious than previous variants.
It's still unclear whether Delta is also more dangerous, but early data can't rule that out, and on Tuesday the Centers for Disease Control and Prevention upgraded Delta to "a variant of concern," a more serious category than it had been in before.
https://www.usatoday.com/story/news/health/2021/06/16/delta-variant-us-risk-effect-vaccine-efficacy/7692591002/
QNTA is very much undervalued.
The true value of it is astronomical.
It is too early in the process to determine how long and how high the value will go.
April 13, 2020
Quanta, Inc. 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.
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.”
IND for Covid-19 therapeutic use first and then others to follow.
Scorpion Venom has the potential to be used in many areas for solutions to different diseases.
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.
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.
Patent
The basic principle described in the US Patent # US 8097284 B2 leads to molecular excitement of vibration produced by an electromagnetic field generator, leading to absorption of the quanta of energy for higher potency of the blue scorpion extract, which increases its effectiveness on overall human health at a deep cellular level. Specific frequencies, as well as harmonics, are used to achieve a resonance effect between the generated electromagnetic frequencies and the molecular frequency of the small molecular peptide, specific amino-acids and 59 essential minerals contained in the blue scorpion extract; the electromagnetic vibrational frequency acts as an energy donor and components contained in the scorpion extract act as an energy acceptor. This energy transfer gives more strength, force and potency to the Blue Scorpion extract.
Polarization Technology
A specifically generated monopole electromagnetic vibration creates a resonance effect with Escozine™’s main ingredients at the molecular level; this leads to absorption of energy and shortens the orbital movement of atoms which, in turn, leads to the increase of activity of polarized molecules, and intensifying their potency. Polarization increases the molecular vibration and is excited when the molecule absorbs a quantum of energy, E, corresponding to the vibration’s frequency, ?, according to the relation E = h? (where h is Planck’s constant). A fundamental vibration is excited when one such quantum of energy is absorbed by the molecule in its ground state. This patented technology allows less compounds to be used while increasing the effectiveness of Escozine™’s main ingredients.
Continuation of Patent
Medolife is in the process of applying for a patent continuation, in which these new topics will be covered in detail:
1. Pet product version of patent applies to all different applications of polarized scorpion venom solution for cats and dogs as well as livestock. To find out more, please visit Petlife Pharmaceuticals.
2. The first application of the polarization technology has more general impact on the Blue Scorpion extract, where new multiple frequency generation allows it to target several components in Escozine™ simultaneously. This addition of the patent will be geared towards increasing the potency of specific molecules in the compound to achieve a greater effect on the targeted molecules, amino acids, proteins and peptides. This polarization approach can be applied to any nutraceutical to increase the potency and effectiveness without adding additional ingredients.
3. Escozine GNP-1 is in research and development as an advanced anti-cancer drug. The polarized gold nanoparticles combined with a novel peptide, extracted from the Caribbean Blue Scorpion venom, enhance the bioactive compound and increase 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.
What does the life of an IND look like?
Once an initial IND application is submitted, the FDA has 30 calendar days to review it. If a clinical hold appears to be warranted, the FDA will notify the Sponsor immediately during this 30-day window. But since IND applications are not formally approved, the FDA might not provide feedback to the Sponsor if there are no concerns surrounding the IND. If the Sponsor does not hear from the FDA within 30 days, the IND goes into effect (becomes “active”).
After an IND goes into effect, the Sponsor is allowed to proceed with their clinical program. However, if the Sponsor has not heard from the FDA, we still recommend that the Sponsor check in with their FDA project manager before starting clinical trials. Doing so can prevent bad news from popping up unexpectedly, and can preclude the need to put a clinical program on hold right after the program is initiated.
It’s important to remember that an IND is a “living application” (or set of documents); it needs to be maintained by the Sponsor in an “active state.” This is accomplished by submitting required amendments to the IND as the development program progresses through the well-known phases. Additionally, IND annual progress reports need to be submitted each year (within 60 days of the date that the IND went into effect). An IND is also updated outside of the annual report window with items such as important clinical/nonclinical data, new protocols, expedited safety reporting, and major manufacturing changes.
Once an NDA is approved, the associated IND is typically closed. Alternately, if the Sponsor plans to run additional clinical trials under the IND, the Sponsor may elect to keep the IND open. It is, however, important to remember that as long as an IND is open (or “active”), the FDA will expect to see annual reports for that IND (in addition to any NDA submissions, including NDA annual reports).
http://www.impactpharma.com/blog/ins-outs-inds/
Naked Short Selling: The Truth Is Much Worse Than You Have Been Told
Click on link for entire story:
https://www.investmentwatchblog.com/naked-short-selling-the-truth-is-much-worse-than-you-have-been-told/
There is a massive threat to our capital markets, the free market in general, and fair dealings overall. And no, it’s not China. It’s a homegrown threat that everyone has been afraid to talk about.
It is big money involved and they rather break the rules pay a fine because the fine is minuscule to the amount of money being made.
The thing about shorting though is when a stock pops for a catalyst and the bulls take over game over for the shorts.
It the article was very clear that weak companies were the common target.
I just shared the article as I thought it was well written and presented what is going on with naked shorting, what the regulators are doing about it (very little) and how much money is involved.
The article has no bearing on whether I invest or not.
I just shared some bits of information from the article however there is a wealth of information in the article including actions taken by the wallstreetsbet and regulators.
Do you think this article is false.
Naked Short Selling: The Truth Is Much Worse Than You Have Been Told
Click on link for entire story:
https://www.investmentwatchblog.com/naked-short-selling-the-truth-is-much-worse-than-you-have-been-told/
There is a massive threat to our capital markets, the free market in general, and fair dealings overall. And no, it’s not China. It’s a homegrown threat that everyone has been afraid to talk about.
The news is just an update of on-going studies. They are going well and hopefully sooner than we can get them completed and get an application to the FDA for Human testing. PFizer has a similar product that is already in human trials which is a plus for us when we go to the FDA with our application. Many different drugs will be created to treat Covid-19 however Pfizer's and Sunshine's are the only two I know of (there are most likely more) that come in a pill form.
The pill form will be a "game changer" as one would not have to go to the hospital or have a health care provider present to administer the treatment as must be done for current antiviral drug via a needle in the skin (intravenously). Also the pill will probably be cheaper to make, transport and have a longer shelf life.
The BOTTOM LINE is just simply HUGE!!!
That being said the Covid-19 is just the appetizer, the MAIN COURSE is the CANCER treatments that are in development.
Montreal, Quebec, Canada – (GLOBE NEWSWIRE) – Sunshine Biopharma Inc. (OTC PINK: “SBFM”), a pharmaceutical company focused on the research, development and commercialization of oncology and antiviral drugs; today confirmed that its COVID-19 mice study currently underway at the University of Georgia is progressing as planned. The study assesses the efficacy of two protease inhibitors in preventing transgenic mice challenged with SARS-CoV-2 from progressing to illness and death. Should these studies prove successful, the Company plans to file the data with the FDA and request authorization to do testing in actual COVID-19 patients. Sunshine Biopharma’s protease inhibitor treatment is anticipated to be orally available, making it possible for the treatment to be in tablet form, which can be taken at home.
“We are moving the project forward as fast as possible, albeit within the constraints of science,” said Dr. Steve Slilaty, CEO of Sunshine Biopharma. “We are optimistic that our research efforts will culminate in a drug that will help turn the page on the pandemic,” he added.
Thanks Koog for your input. It is appreciated.
ENZC has being using AI long before INTEL reached out.
AI is just a tool ENZC uses to get to their end results quicker.
ENZC primary goals are to produce Monoclonal Antibodies to treat and possibly cure diseases.
The company has done quite well without INTEL and is able to reach the goals quicker with their toolkit.
It is a win win win situation for ENZC, INTEL and all the people these antibodies will help.
I have a question for you:
What brought you to the ENZC board?
Coronavirus mutated 32 times inside South African HIV-positive woman over course of seven months
If more such cases are found, it raises the prospect that HIV infection could be a source of new variants
It is not clear whether the mutations the 36-year-old South African carried were passed on to others
A 36-year-old woman with advanced HIV carried the novel coronavirus for 216 days, during which the virus accumulated more than 30 mutations, a new study has found.
The case report, which has not been peer-reviewed, was published as a preprint on medRxiv on Thursday. The woman, who has not been named, was identified as a 36-year-old living in South Africa.
The coronaviruses gathered 13 mutations to the spike protein, which is known to help the virus escape the immune response, and 19 other mutations that could change the behaviour of the virus.
It is not clear whether the mutations she carried were passed on to others, the Los Angeles Times reported.
If more such cases are found, it raises the prospect that HIV infection could be a source of new variants simply because the patients could carry the virus for longer, Tulio de Oliveira, a geneticist at the University of KwaZulu-Natal in Durban and the study’s author, told the Times.
But it is probably the exception rather than the rule for people living for HIV, because prolonged infection requires severe immunocompromise, Dr Juan Ambrosini, associate professor of infectious diseases at the University of Barcelona, said. Indeed, the woman in the case study was immunosuppressed.
The findings are important for the control of Covid-19 because these patients could be a continuous source of transmission and evolution of the virus, Ambrosini said.
Immunosuppressed patients could carry the coronavirus longer than others.
This case could easily have gone unnoticed, de Oliveira told the Times . This was because after the woman was treated in hospital for her initial symptoms, she displayed only mild symptoms of Covid-19, even though she was still carrying the coronavirus, de Oliveira said.
Scientists only spotted this case because she was enrolled in a study on 300 people with HIV looking at their immune response to Covid-19.
The researchers also found that four other people with HIV had carried the coronavirus for longer than a month, they told the Times.
Only one other case of a person with HIV carrying the coronavirus for a prolonged period of time had been published previously.
Some patients who have been immunosuppressed for other reasons have been seen to carry the coronavirus for prolonged periods of time, Ambrosini said. For instance, he said, there have been reported cases of people with kidney transplants testing positive for almost a year.
The finding could be of particular importance for Africa – which had 20.6 million out of its 37.6 million people living with HIV in 2020. The WHO on Friday warned that a sharp rise in infections could turn into a continent-wide third wave of Covid-19.
https://www.scmp.com/news/world/africa/article/3136136/woman-hiv-had-covid-19-seven-months-virus-mutated-32-times-inside?utm_source=rss_feed
It is all about the Peptides.
Why the FDA ask for samples of Escozine.
Medolife Rx Submits Final Data Set to FDA for IND Filing on Lead Drug Candidate
Download as PDFAPRIL 13, 2021 8:30AM EDT
BURBANK, Calif., April 13, 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 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.
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.
As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered drugs.
I wonder what they are doing with the batch they received form QNTA.
The ingredient from the Scorpion Venom that is WIDELY used in DISEASE fighting arena is PEPTIDES.
If one was to research peptides in the disease fighting arena one would understand the HUGE potential that QNTA/MEDOLIFE have at its finger tips.
Escozine™ is a natural compound extracted from the Caribbean Blue Scorpion (Rhopalurus Princeps), which, in its original form, contains low molecular weight peptides, amino acids, proteins and 59 minerals. We have used modern technologies to isolate and filter the essential minerals. The extracted minerals have been polarized by a patented methodology (#US 8,097,284 B2) to increase the potency and binding preferences with abnormal cells. Escozine™ has several paths of influence that affect abnormal cells. The main compound induces Potassium (K+) 3-4 kDa, Sodium (Na+) 6- - 8 kDa and Chloride (Cl+) ionic channel inhibitors.
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.
We are Good
We are Golden
BOOM TIME Coming
Research indicates that bioactive peptides may :
lower high blood pressure.
kill microbes.
reduce inflammation.
prevent the formation of blood clots.
improve immune function.
act as antioxidants.
Peptides for Health Benefits 2019
In recent years, peptides have received increased interest in pharmaceutical, food, cosmetics and various other fields. The high potency, specificity and good safety profile are the main strengths of bioactive peptides as new and promising therapies that may fill the gap between small molecules and protein drugs. Peptides possess favorable tissue penetration and the capability to engage into specific and high-affinity interactions with endogenous receptors. These positive attributes of peptides have driven research in evaluating peptides as versatile tools for drug discovery and delivery. In addition, among bioactive peptides, those released from food protein sources have acquired importance as active components in functional foods and nutraceuticals because they are known to possess regulatory functions that can lead to health benefits.
This Special Issue of International Journal of Molecular Sciences represents the second in a series dedicated to peptides. This issue includes thirty-six outstanding papers describing examples of the most recent advances in peptide research and its applicability.
The Special Issue begins with a group of papers exploring aspects of synthetic peptides that are of significance to develop novel drugs for controlling and/or managing chronic diseases. It begins with a study of Gaglione et al. [1] on the identification of three cryptides in human apolipoprotein B and evaluation of their antimicrobial and anti-biofilm properties individually or in combination with ciprofloxacin towards Pseudomonas and Burkholderia strains clinically isolated from cystic fibrosis patients. These findings will open interesting perspectives to apoB cryptides applicability in the treatment of chronic lung infections associated with cystic fibrosis disease. The issue follows with research by Tarallo et al. [2] on a new tetrameric tripeptide inhibitor of vascular endothelial growth factor receptor 1 that exerts anti-angiogenic activity at ocular level by oral delivery in a preclinical model of age-related macular degeneration. Asai et al. [3] demonstrate that Pro-Hyp and Hyp-Gly play crucial roles in proliferation of fibroblasts attached on collagen gel. Russjan and Kaczynska [4] investigate the beneficial effects of neurotensin in murine model of hapten-induced asthma. In another paper, Russjan et al. [5] investigate the anti-inflammatory potency of hybrid peptide-PK20, composed of neurotensin and endomorphin-2 pharmacophores in a mouse model of non-allergic asthma. Improved anti-inflammatory potency of the hybrid over the mixture of its moieties shows potential as a promising tool in modulating airway inflammation in asthma. Pershina et al. [6] study the gender specific effects of a pegylated glucagon-like peptide 1 (GLP-1), used in the treatment regime for metabolic disorder and chronic obstructive pulmonary disease. Oludiran et al. [7] demonstrate that potency of antimicrobial piscidin peptides depends on environmental oxygen, therefore, the development of pharmaceuticals from host-defense peptides such as piscidin will necessitate consideration of oxygen levels in the targeted tissue. The chemokine-like activity of the synthetic dipeptide pidotimod is studied by Caccuri et al. [8]. The study also defines the mechanism of action for chemokine-like activity of pidotimod and points on the possible role that this synthetic dipeptide may play in leukocyte trafficking and function. The potency, toxicity and mechanisms of action of Ps-K18 is examined by Jang et al. [9] aiming to develop antibiotics derived from bioactive peptides for the treatment of Gram-negative sepsis. Golda et al. [10] screen a library of synthetic peptides to identify those with antibacterial potential against multidrug-resistant Staphylococcus aureus. The bactericidal and keratinocytes cytoprotective mechanisms against invading bacteria are also elucidated. Staphylococcus aureus and Pseudomonas aeruginosa, individually or in co-occurrence, are the two main pathogens implied in multiple bacterial infections. Since their discovery, the antimicrobial peptides (AMPs) of innate defense have been considered as a potential alternative to conventional antibiotics. However, no commercial AMPs are still available. The review of Roncevic et al. [11] is aimed at describing these peptides, their mechanisms of action, their biological and biophysical properties as well as the developed models to design and produce new molecules with high antimicrobial potency and low toxicity. Intragenic antimicrobial peptide Hs02 is demonstrated by Bessa et al. [12] to exert antimicrobial properties against Pseudomonas aeruginosa and Staphylococcus aureus, also hampering the proliferation of their single and dual-species biofilms. The study of Prasad et al. [13] reviews the role of host defense peptides in different inflammatory conditions and diseases, associating this role with the physicochemical properties of peptides and their interaction with various receptors that define their immunomodulatory effects. In another paper, Nácher-Juan et al. [14] investigate the role of peptide osteostatin derived from parathyroid hormone-related protein against rheumatoid arthritis. This peptide, administered to collagen-induced arthritic mice, decreases the severity of the disease through modulation of immune and inflammatory biomarkers. Palus et al. [15] report the neurothropic and/or neuroprotective properties of galanin, alone or in combination with other neuroactive substances such as vasoactive intestinal peptide, neuronal nitric oxide synthase and cocaine- and amphetamine-regulated transcript peptide in the recovery processes in the stomach enteric nervous system neurons following acrylamide intoxication. The extra domain B of fibronectin (EDB-FN) localized in the extracellular matrix can differentiate aggressive prostate cancer from benign prostatic hyperplasia. Park et al. [16] synthesize two cyclic peptides, CTVRTSADC and KTVRTSADE with ability to target EDB-FN, and develop different conjugates with anticancer drugs docetaxel and doxorubicin. The conjugates show selective cytotoxic effects against prostate cancer cells without affecting normal prostate cells.
Following, there is a short series of articles dealing with the elucidation of modes of action of known food-derived bioactive peptides. Fernández-Tomé et al. [17] provide new evidence on the chemopreventive activity of peptide lunasin, a bioactive peptide from soybean and other vegetal sources, on colorectal cancer by modulating both the parental and the tumorsphere-derived subsets of HCT-116 cells. The underlying molecular mechanisms behind the inhibitory effects of lunasin on cell cycle progress of colon cancer cells and cytotoxicity were also discussed. Martínez-Sánchez et al. [18] describe the beneficial effects of dry-cured ham peptides previously identified to prevent from endothelial dysfunction and inflammation. In silico dockings show the predicted modes of binding of four bioactive peptides with the regulatory subunit NEMO of the NF-?B transcription factor and angiotensin I converting-enzyme.
Another group of papers explores the potential of new proteins as sources of bioactive peptides. Cai et al. [19] explore the cytoprotective mechanism of antioxidant pentapeptides from a protein hydrolysate of miiuy croaker (Miichthys miiuy) swim bladder against oxidative damage to human umbilical vein endothelial cells. Gomez et al. [20] report on the potential bioactivities of Portuguese oyster (Crassostrea angulata) proteins through in silico analyses and in vitro tests. C. angulata proteins were proven to be sources of angiotensin I-converting enzyme and dipeptidyl peptidase IV inhibitory peptides with pharmaceutical and nutraceutical applications. Using different commercial proteases, Ding et al. [21] produce hydrolysates from velvet antler with antioxidant properties. The protective effect against oxidative stress of a tetrapeptide produced by Alcalase is investigated in Chang liver cells and a zebrafish model. León-Lopez et al. [22] describe the biochemical, structure and physico-chemical features as well as the antioxidant activity of collagen hydrolysates from sheepskins. A soybean product obtained after combined hydrolysis with Prozyme and fermentation with Lactobacillus rhamnosus EBD1 by Daliri et al. [23] show antihypertensive properties in both in vitro and in vivo models, without losing its activity after simulating its digestion by gastrointestinal enzymes. Peptides PPNNNPASPSFSSSS, GPKALPII and IIRCTGC, in which angiotensin-converting enzyme inhibitory activity had been previously demonstrated, are included in the soy product. Another review of Brady et al. 24 summarizes the antibacterial and anti-inflammatory activities of cecropins, a group of naturally occurring antimicrobial peptides found in insects. The strategies designed to overcome the existing limitations linked to their costly large-scale production and their use as therapeutic agents are also described.
The issue includes some studies on bioinformatic and proteomic tools useful for peptide research. Using molecular docking, Chamata et al. [25] describe the structure-activity relationships of peptide sequences present in whey/milk protein hydrolysates with high angiotensin converting enzyme inhibitory activity to a better understanding and prediction of their in vivo antihypertensive activity. Minkiewicz et al. [26] review the new opportunities offered by the BIOPEP-UWM database of bioactive peptides that include the possibility of annotating peptides containing D-enantiomers of amino acids, batch processing option, converting amino acid sequences into SMILES code, new quantitative parameters characterizing the presence of bioactive fragments in protein sequences and finding proteinases that release particular peptides. Using yeast proteome microarrays, Shah et al. [27] identify a total of 140 and 137 intracellular protein targets of antifungal peptides of Lactoferricin B and Histatin-5, respectively. The usefulness of this proteomic tool to find synergistic actions of bioactive peptides is also addressed. The in silico analysis carried out by Tejano et al. [28] reveal the role of Chlorella sorokiniana proteins as source of bioactive peptides. The BIOPEP’s profile shows that these proteins have multiple dipeptydil peptidase IV inhibitors, glucose uptake stimulants, antioxidant, regulating, anti-amnestic and anti-thrombotic peptides. Pepsin, bromelain and papain are the main proteases responsible for the release of bioactive peptides with pharmaceutical and nutraceutical potential. The review of Bozovicar and Bratkovic [29] focuses on recombinant peptide libraries useful for pharmaceutical industry in the drug discovery and delivery. These authors discuss different platforms for the display and/or expression of bioactive peptides as well as various diversification strategies for library design.
Another group of papers explores the effects of endogenous peptides on body functions and their potential for new drug alternatives. In a glioma mouse model, Kucheryavykh et al. [30] reveal by ELISA and immunofluorescence images that innate amyloid beta (Aß) peptide is accumulated in glioma tumors and nearby blood vessels. Interestingly, the amyloidogenic Aß peptide is co-localized with the lipid-free apolipoprotein E (apoE) in amyloid plaques in Alzheimer’s disease, where the apoE4 isoform plays a crucial role for the late onset disorder. In the study of Tsiolaki et al. [31], apoE peptide-analogues serve to predict the dynamics of apoE and apoE-Aß complexes. The homeostasis of the organism is maintained by coordinated neuroendocrine and immune systems. Vasoactive intestinal peptide (VIP) is an endogenous neuropeptide produced by both neurons and endocrine and immune cells. Martínez et al. [32] review the biology of VIP and VIP receptor’s signaling and their protective immunomodulatory effects. The current evidence on strategies improving the stability, selectivity and effectiveness of VIP receptors analogs, the advances on new routes of administration and the potential clinical benefits against inflammatory and autoimmune disorders is described. Another neuropeptide described in the Special Issue is the prolactin-releasing peptide (PrRP). The anorexigenic neuroprotective effects of this peptide are reviewed by Pražienková et al. 33. These authors also describe its therapeutic potential mediated by its actions on cardiovascular system, pain and stress. G-protein-coupled-seven-transmembrane receptors (GPCRs) are known by their modulatory properties of myeloid cell trafficking in microbial infections, inflammation, immune response and cancer progression. The review of Krepel and Wang 34 shows the existing evidence on one of these receptors from murine origin, called Fpr2, and its endogenous agonist peptide, cathelicidin-related antimicrobial peptide. Both are implied in normal mouse colon epithelial growth, repair and protective actions against inflammation-associated tumorigenesis.
Finally, a couple of articles describe new developed techniques to investigate the response of immune system. Thus, Kametani et al. [35] describe humanized mouse systems possessing immune cells as successful models to in vivo investigate the human immunity and predict the antibody response and immune adverse effects. Similarly, immune responses can be studied using an in situ mayor histocompatibility complex tetramer staining. As described by Abdelaal et al. [36], this technique, combined with immunohistochemistry, is a valuable tool for studying the Ag-specific T cell immune response in tissues. Combined techniques enable determining the localization, abundance and phenotype of T cells and characterizing Ag-specific T cells in specific tissues. Current applications in microbial infections, cancer and autoimmunity are also reviewed.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7178072/
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.
QNTA increased their authorized shares from 100,000,000 to 500,000,000 on November 30, 2020.
QNTA increased their authorized shares from 500,000,000 to 3,000,000,000 on May 28, 2021 and also changed the company’s name, to effect the change of the symbol and give the board of directors the right to effect a reverse split of the stock.
Outstanding Shares 176,458,527 05/22/2021
QNTA is a company with tremendous potential and has many catalysts waiting to be revealed. The company has positioned itself with the increase in authorized shares to have the ability to raise capital as necessary to finance additional growth.
Just because they have the right to effect a reverse split doesn’t mean it will ever happen. As the company is able to generate more revenue moving forward the selling of shares to finance the company will become less of an issue.
Patience is key as we should see many results from the company’s initiatives come to fruition in the upcoming days, weeks and months.
QNTA closing stock price has fluctuated as low as 0.0398 to a high of 0.1951.
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.
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.
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.
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.
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.
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.
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.
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.”
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.”
May 4, 2021
Medolife Rx Announces Historic Product Registration in Dominican Republic Enabling Escozine to Be Sold Throughout Latin America as Natural Alternative Cancer Medicine
May 6, 2021
Medolife Rx Implements Proprietary Electro Solution, Further Increasing Efficacy of Polarization Technology
May 13, 2021
Medolife Rx Announces New Extraction Facility and Scientific Team in Place
May 20, 2021
Medolife Rx Completes Initial Meeting with Bioethics Committee, Preparing for Commencement of Phase II Clinical Trial on Lead Drug Candidate
May 27, 2021
Medolife Rx Successfully Produces Medical Batch of Escozine Through In-house Facilities, Ready for Submission to DR Ministry of Health for Further Trials
June 1, 2021
Medolife Rx Launches National TV PSA Campaign Promoting Escozine and Activates Customer Service Center
June 3, 2021
Medolife Rx Schedules Investor Webcast for Tuesday June 8, 2021
https://finance.yahoo.com/quote/QNTA/?p=QNTA
QNTA increased their authorized shares from 100,000,000 to 500,000,000 on November 30, 2020.
QNTA increased their authorized shares from 500,000,000 to 3,000,000,000 on May 28, 2021 and also changed the company’s name, to effect the change of the symbol and give the board of directors the right to effect a reverse split of the stock.
Outstanding Shares 176,458,527 05/22/2021
What Is Capital Stock?
Capital stock is the total amount of stock, both common and preferred, that a public company has the authorization to issue. The difference between common stock and preferred stock is that if a company goes bankrupt, preferred stockholders receive their share of the assets before common stockholders receive theirs (if there's anything left).
Benefits of Increasing Capital Stock
Despite possible dilution of shares, increases in capital stock can ultimately be beneficial for investors. The increase in capital for the company raised by selling additional shares of stock can finance additional company growth. If the company invests the additional capital successfully, then the ultimate gains in stock price and dividend payouts realized by investors may be more than sufficient to compensate for the dilution of their shares.
It is a good sign to investors and analysts if a company can issue a significant amount of additional stock without seeing a significant drop in share price.
QNTA is a company with tremendous potential and has many catalysts waiting to be revealed. The company has positioned itself with the increase in authorized shares to have the ability to raise capital as necessary to finance additional growth.
Just because they have the right to effect a reverse split doesn’t mean it will ever happen. As the company is able to generate more revenue moving forward the selling of shares to finance the company will become less of an issue.
Patience is key as we should see many results from the company’s initiatives come to fruition in the upcoming days, weeks and months.
QNTA closing stock price has fluctuated as low as 0.0398 to a high of 0.1951.
For the quarterly period ended September 30, 2020
NOTE 12 – SUBSEQUENT EVENTS
On November 20, 2020, the Board of Directors approved an increase in the Company’s authorized shares of Common Stock from 100,000,000 to 500,000,000 shares by Unanimous Written Consent in order to provide the Company with sufficient shares to adequately pay down its debt, to allow for compensation to vendors and executives for ongoing services being rendered to the Company, and to accommodate for future financings and acquisitions. On November 20, 2020, the Board Received the Majority Shareholder’s Consent from Phil Sands, holder of 2,500,000 shares of our Series A Preferred Stock, approving the increase in our authorized shares of Common Stock to 500,000,000. No changes to our Preferred Stock are being made. The Secretary of the state of Nevada approved the amendment to the articles of incorporation and approved the share increase.
https://ir.quantrx.com/sec-filings/all-sec-filings?form_type=&year=2020##document-383-0001493152-20-023907-2
SCHEDULE 14C INFORMATION
NOTICE IS HEREBY GIVEN that the following action has been approved pursuant to the written consent of the holders of a majority of the voting power of the outstanding common stock of Quanta Inc., a Nevada corporation (the “Company”, “we”, “us”, or “our”) dated May 28, 2021, in lieu of a special meeting of the stockholders and in accordance with Section 78.315(2) of the Nevada Revised Statutes:
To amend the Company’s Articles of Incorporation, to change the number of authorized shares of common stock of the Company to 3,100,000,000, $0.001 par value consisting of 3,000,000,000 ( Three Billion) and to increase the number of Preferred Shares to 100,000,000 of which 2,500,000 shares are designated as Series A Preferred Stock, 9,000 shares are designated as Series B Preferred Stock, 1,000 are designated as Series C Preferred Stock and the remainder of the Preferred Stock shall have rights, preferences and privileges to be established by the Board of Directors.
To amend the Company’s Articles of Incorporation, to change the name of the Company to Medolife Rx Holdings, Inc.
To effect the change of the symbol of the Company.
To grant the Board of Directors of the Company, for a period of 12 months, the right to effect a reverse stock split with a range between 1 for 10 to 1 for 500 for all outstanding shares of stock
https://ir.quantrx.com/sec-filings/all-sec-filings?form_type=PRE+14C&year=##document-425-0001493152-21-013407-2
When boom time comes it will sneak up on us totally expected just don't know when.
The thing about biotechs is that big money will move in when their desired milestones are met.
We already know one of the Big Pharma's is interested after the animal studies are done.
Right on.
We have very good prospects.
It is just a waiting game.
Biotech takes time due to protocols and rightly so.
Drugs going into people bodies should be scrutinized closely.
My third one uses Scorpion Venom for its peptide.
TO DA MOON
We all heard it.
This stock is going TO DA MOON.
Some stocks do go TO DA MOON and I”m holding 3 that have the potential to go TO DA MOON. These stocks are my trifecta play.
I’m hopeful that they all go To DA MOON.
What is very interesting is that these stocks have many similarities.
All are biotechs.
All have a potential Covid-19 solution.
All have a potential cancer solution.
All are OTC stocks.
The best companies deliver the most shareholder value by creating a product that radically changes the face of medicine. Amgen revolutionized patient care in chemotherapy. Celgene addressed tough diseases with its own discoveries. In 2021, we're seeing the fruits of messenger RNA technology leading to the rapid development of Covid-19 vaccines.
All 3 of these companies have the potential to radically change the face of medicine.
Biotechnology is a sector where traders seek out these huge profits. For smart traders, this sector can present an incredible area of opportunity, but for those who are not willing to do their homework, it can be a train wreck waiting to happen.
Have you done your homework?
Is QNTA one of my trifectas?
Why of course it is.
Some of you are holding the other 2 which suggest some serious DD has been going on.
Few sectors in the market see small single-product companies go from having tiny market capitalizations to having a worth over hundreds of millions practically overnight. The business of curing diseases can be a lucrative one, and investors will jump on the bandwagon for any stock that shows the promise of a big breakthrough.
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.
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.”
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.
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/
As the above information suggests, it will take time for new drugs to go through the regulatory process so PATIENCE is necessary.
It really is exciting to have 3 Biotechs that all of which possess technology that can have a tremendous impact on humanity.
TO DA MOON
We all heard it.
This stock is going TO DA MOON.
Some stocks do go TO DA MOON and I”m holding 3 that have the potential to go TO DA MOON. These stocks are my trifecta play.
I’m hopeful that they all go To DA MOON.
What is very interesting is that these stocks have many similarities.
All are biotechs.
All have a potential Covid-19 solution.
All have a potential cancer solution.
All are OTC stocks.
The best companies deliver the most shareholder value by creating a product that radically changes the face of medicine. Amgen revolutionized patient care in chemotherapy. Celgene addressed tough diseases with its own discoveries. In 2021, we're seeing the fruits of messenger RNA technology leading to the rapid development of Covid-19 vaccines.
All 3 of these companies have the potential to radically change the face of medicine.
Biotechnology is a sector where traders seek out these huge profits. For smart traders, this sector can present an incredible area of opportunity, but for those who are not willing to do their homework, it can be a train wreck waiting to happen.
Have you done your homework?
Is SBFM one of my trifectas?
Why of course it is.
Some of you are holding the other 2 which suggest some serious DD has been going on.
Few sectors in the market see small single-product companies go from having tiny market capitalizations to having a worth over hundreds of millions practically overnight. The business of curing diseases can be a lucrative one, and investors will jump on the bandwagon for any stock that shows the promise of a big breakthrough.
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.
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.”
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.
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/
As the above information suggests, it will take time for new drugs to go through the regulatory process so PATIENCE is necessary.
It really is exciting to have 3 Biotechs that all of which possess technology that can have a tremendous impact on humanity.
TO DA MOON
We all heard it.
This stock is going TO DA MOON.
Some stocks do go TO DA MOON and I”m holding 3 that have the potential to go TO DA MOON. These stocks are my trifecta play.
I’m hopeful that they all go To DA MOON.
What is very interesting is that these stocks have many similarities.
All are biotechs.
All have a potential Covid-19 solution.
All have a potential cancer solution.
All are OTC stocks.
The best companies deliver the most shareholder value by creating a product that radically changes the face of medicine. Amgen revolutionized patient care in chemotherapy. Celgene addressed tough diseases with its own discoveries. In 2021, we're seeing the fruits of messenger RNA technology leading to the rapid development of Covid-19 vaccines.
All 3 of these companies have the potential to radically change the face of medicine.
Biotechnology is a sector where traders seek out these huge profits. For smart traders, this sector can present an incredible area of opportunity, but for those who are not willing to do their homework, it can be a train wreck waiting to happen.
Have you done your homework?
Is ENZC stock one of my trifectas?
Why of course it is.
Some of you are holding the other 2 which suggest some serious DD has been going on.
Few sectors in the market see small single-product companies go from having tiny market capitalizations to having a worth over hundreds of millions practically overnight. The business of curing diseases can be a lucrative one, and investors will jump on the bandwagon for any stock that shows the promise of a big breakthrough.
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.
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.”
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.
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/
As the above information suggests, it will take time for new drugs to go through the regulatory process so PATIENCE is necessary.
It really is exciting to have 3 Biotechs that all of which possess technology that can have a tremendous impact on humanity.
Sunshine Biopharma, Inc. (OTCMKTS:SBFM) The Bull Has Awoken
July 18, 2020
Sunshine Biopharma, Inc. (OTCMKTS:SBFM) is moving up in a hurry on heavy accumulation, breaking out over current levels and surging over a penny on massive volume. The stock is quickly attracting legions of shareholders who continue to bid SBFM higher.
It’s easy to get excited about SBFM here; the Company recently filed a patent application for a new coronavirus COVID-19 Treatment. Sunshine Biopharma’s patent application covers composition subject matter pertaining to small molecules for inhibition of the main Coronavirus protease (Mpro), an enzyme that is essential for viral replication. The small molecules covered by the patent application were computer modelled and designed by Dr. Steve N. Slilaty, CEO of Sunshine Biopharma.
Sunshine Biopharma, Inc. (OTCMKTS:SBFM) is a fully integrated pharmaceutical company offering generic and proprietary drugs for the treatment of cancer and other acute and chronic indications. Since inception, SBFM proprietary drug development activities have been focused on the development of a small molecule called Adva-27a for the treatment of aggressive forms of cancer. A Topoisomerase II inhibitor, Adva-27a has been shown to be effective at destroying Multidrug Resistant Cancer cells including Pancreatic Cancer cells, Breast Cancer cells, Small-Cell Lung Cancer cells and Uterine Sarcoma cells. Sunshine Biopharma is direct owner of all issued and pending worldwide patents pertaining to Adva-27a including U.S. Patents Number 8,236,935 and 10,272,065.
Microcapdaily has been covering SBFM for many years; on April 4, 2016 we covered the stock commenting “Sunshine Biopharma, Inc. (OTCMKTS:SBFM) is making an explosive move up on accelerating volume since reversing off $0.0121 lows last week. The stock does have a history of big moves running from well under $0.25 to highs over $1.25 in 2011.
https://microcapdaily.com/sunshine-biopharma-inc-otcmktssbfm-the-bull-has-awoken/126598/
What will Sunshine BioPharma stock being doing JULY 2021?
How To Trade Biotech Stocks: Can These Three Tips Help You Make More Profits?
With hundreds of companies forming IBD's biotechnology industry group, investors naturally seek big profits in the ever-dynamic space. And why not? Huge breakouts and five-, tenfold moves by the likes of Amgen (AMGN), Biogen (BIIB), Celgene (acquired by Bristol Myers Squibb (BMY)), Genentech (acquired by Roche (RHBBY)) and Regeneron Pharmaceuticals (REGN) have become Wall Street lore.
But are there some practical tips to help you consistently make money in the stock market — especially in this volatile field of industry? Consider three.
Tip No. 1:
Try a scattershot approach. Buy a highly liquid exchange traded fund such as the SPDR S&P Biotech (XBI) ETF. It ranks among leading ETFs tracked by IBD. Want more juice? ProShares Ultra Nasdaq Biotechnology (BIB) seeks to deliver twice the return of the Nasdaq Biotechnology Index. One big problem: It can crush your portfolio during steep market downturns. So, be disciplined with timing. Buy only when you see a follow-through day after a bear market. The Big Picture can help in this regard.
Tip No. 2:
The best companies deliver the most shareholder value by creating a product that radically changes the face of medicine. Amgen revolutionized patient care in chemotherapy. Celgene addressed tough diseases with its own discoveries. In 2021, we're seeing the fruits of messenger RNA technology leading to the rapid development of Covid-19 vaccines.
You don't have to grab shares in huge winners by trying to pick the bottom. Instead, look for companies that form good bases that signal heavy institutional accumulation.
Tip No. 3? Marc Lichtenfeld, an expert in biotech and income stocks, notes that a lot of Wall Street money moves into companies that issue positive Phase 2 clinical trial data. Such news can spark big breakouts and solid price runs over the span of months or a few years. But few companies succeed as well when they get to Phase 3 of a drug trial.
https://www.investors.com/how-to-invest/investors-corner/how-to-trade-biotech-stocks-three-tips-help-make-more-profits/
Biotechnology is a sector where traders seek out these huge profits. For smart traders, this sector can present an incredible area of opportunity, but for those who are not willing to do their homework, it can be a train wreck waiting to happen. We'll use real-life examples to illustrate why this sector can be so appealing and what issues you should consider before putting your capital at risk.
KEY TAKEAWAYS
Investors are often tempted to look at the biotech sector for high return investments.
Investing in biotech, however, comes with risks, in part due to the fact that many of the products being researched or developed will never make it to market.
Biotech firms face many regulations as well, including from the FDA, which adds risk to the already volatile nature of developing new drugs.
The products produced in this sector are complex, where it would take the average investor significant time to understand the factors that affect the product’s chances of success.
Even large financial institutions tend to have a poor track record when it comes to predicting the performance of these companies.
The Big Win
Few sectors in the market see small single-product companies go from having tiny market capitalizations to having a worth over hundreds of millions practically overnight. The business of curing diseases can be a lucrative one, and investors will jump on the bandwagon for any stock that shows the promise of a big breakthrough.
As an example, as you can see in Figure 1, Novavax Inc. (NVAX) rose from a low of $0.74 in August 2005 to a high of $8.31 in March 2006. This is equal to an amazing 1,023% in seven short months. With gains like this, it is easy to see why so many are anxious to put money into this sector.
It's Not All Roses
You can't always put down $10,000 and come back in seven months to collect $102,300. Along with the opportunity to make huge gains comes the potential for some very devastating losses. Because most of the companies in this sector are relatively small, with no more than two or three products, news releases concerning their clinical trials and/or approval from the Food and Drug Administration (FDA) is one of the main factors deciding the direction of the company's stock. Companies in this sector can live and die by these announcements.
For example, investors of Threshold Pharmaceuticals (THLD) saw the price of their shares travel to a high of $16.98 in mid-April 2006 only to fall to a low of $3 in mid-May 2006. The major fall was attributed to the termination of the company's clinical trials upon the FDA's request. The 82% drop in roughly one month is a good example of what can happen when a company releases this type of bad news.
Even worse, notice in Figure 2 how the stock gaps down. This means that you have no chance of cutting losses once you've entered the trade. As an example, let's say that you bought the stock at around $15 and had a stop-loss order in for $13. In theory, the stop-loss should limit your loss to around $2 ($15 - $13). In volatile markets like this, however, you can't limit your loss. Your order will get filled at the open price of $3, not the $13 you wanted.
The Illusion of the Story
Many investors get wrapped up in the story of a small biotech firm and convince themselves that the company's product(s) will revolutionize its industry. Some investors even place money into these types of companies simply because they believe that complex products seem so impressive that they must work. It's not that impressive-sounding products can't be successful, but rather that it is extremely difficult for the average investor to get a handle on the probabilities of success for a drug.
For example, an investor researching Micromet Inc. (MITI) would have read on its Yahoo! Finance page that "its drug development platform is based on its BiTE technology, an antibody-based format that uses the cytotoxic potential of T-cells. The company's principal product candidates include Adecatumumab (MT201), a recombinant human monoclonal antibody.”
This might sound impressive, but do you have any idea what the company does? Perhaps those of you with doctorates in biology understand, but for the average person (or the average analyst), even understanding the product can be difficult. What this means is that you, the investor, are going to have to do a lot of homework to figure out exactly what the product is, what the company's strategic advances are and what risks are involved in the event that the product does not work.
Nobody Really Knows, Not Even the Big Guys
Since the companies in this sector can be very complicated, many traders will turn to large financial institutions for guidance. The buy and sell ratings made by these companies can be used as a tool to determine whether or not an investment decision should be made, but as you can see in Figure 3, they can be totally wrong.
In our first example, an investment bank issued a buy rating on Valentis Inc. (VLTS) on June 23, 2006. Eleven trading days later, the company released bad news about its drug and the stock fell a whopping 79% in one day. What did the firm that issued the buy rating do? They downgraded the stock to a hold rating. That makes you wonder how poorly a company has to perform to get a sell rating.
Another example of poor financial institution advice occurred on December 8, 2005, when a large investment bank issued a buy rating on DOV Pharmaceuticals Inc. (DOVP). At this point in time, the price was approximately $15, but as you can see in Figure 4, this changed within the next few months as the stock dropped off and hit a low of $2.71. On May 17, 2006, the investment bank came out and (again) issued a hold rating, but this rating was not much help to investors as the stock dropped again, to a new low of $1.85 a month later.
Conclusion
The biotechnology sector is very exciting and can be very rewarding for those who remain cautious and do their homework. However, it is easy to get caught up in the dream of 1,000% gains, or the intriguing stories of how certain companies' products will change the world.
It is important to realize that if you are aiming for huge gains in the biotech sector, you likely will encounter some bad trades that will leave you reeling at the reduction of the value of your account. We all know that investors make mistakes and, as shown above, even the big players can see their picks lose most of their value. If the big players can be completely wrong, so can you, so trade with caution and restraint. When it comes to investing in this high-risk sector, it may be wise to use only as much money as you can afford to lose.
https://www.investopedia.com/articles/trading/06/biotechsector.asp
Biotech stocks frequently make big moves on a single trial result or FDA ruling.
These 8 drugmakers are worth watching amid important events on deck this summer.
We all know that investing in biotech stocks isn't for the faint of heart.
They tend to be pretty volatile, experiencing massive price surges and slumps. The reason for all these swings is simple – biotech stocks trade on catalysts.
Unlike, say, a steady consumer products firm, biotech stocks march to the drum of regulatory approval, the outcomes of trial data and major conference presentations. Often, stocks in the sector will zoom higher or sink lower on these pieces of information.
Then it becomes a waiting game until the next major catalyst.
For investors looking to play in biotech stocks, knowing these important dates is vital for success. The worst thing to do is get caught off-guard and not have an exit strategy if things suddenly get ugly for your investment.
While the start of the calendar year is often prime time for U.S. Food and Drug Administration (FDA) events and trial data to be released, the summer also heats up for drugmakers and biotech stocks. The next few months feature several major events for a number of biotechnology firms and their shareholders.
The key is knowing which events to watch.
Finding Prescription Drug User Fee Act (PDUFA) dates – which are deadlines for the U.S. FDA to review a company's drugs – and other info for these biotech catalysts can be a daunting task. Here, we'll point out several of these dates for investors to mark on their calendars.
https://www.kiplinger.com/investing/602820/biotech-stocks-with-major-catalysts-on-horizon