Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Did he mentioned the r/s or
Did I miss that part?
And no inside buying.....
Buy now or after the r/s?
Another r/s
So it’s better to sell today?
What’s the news?
Wow what a volume
Inside buying??
When will Alice Villalobos will say something about radiogel?
Can we expect another reverse split ?
I lost a lot of money due to the RS’s
But I still believe in the future of radio gel
Waiting for more News
QualityStocks
Posted on 8 March, 2017 10:53
Advanced Medical Isotope Corp. (ADMD) is “One to Watch”
Advanced Medical Isotope Corporation (OTC: ADMD), a late-stage radiation oncology-focused medical device company, has developed a real power play portfolio in the radiotherapy segment of the cancer treatment market, a niche set to hit $11.3 billion on its own by 2025 globally, growing at an estimated 6.7 percent CAGR. Brachytherapy, or placing radioactive implants directly on or into cancerous tissue, is a component of this sector; however, brachytherapy hasn’t seen the kind of traction historically that an innovator like ADMD stands poised to wrest out of it. The brachytherapy market ran about $705 million in 2015 and consisted of a 60/40 mix between HDR/LDR (high- and low-dose radiation) or pulsed therapies on the one hand, and microsphere brachytherapy on the other.
A Market Ripe for Disruption
Even with somewhat innovative developments like microspheres helping to drive growth estimates of some eight percent CAGR for the overall brachytherapy space, and projections of $2 billion by 2030, only ten or so companies currently dominate this heavily consolidated space. Most microsphere solutions pose migration risk, require pretreatment of the patient (which only somewhat mitigates the migration problem), and carry similar risks to other radiotherapies when it comes to the overall impact to surrounding healthy tissues. Microspheres are also typically quite limited in terms of what types of cancers/tissue systems they can effectively address, with liver cancer treatments like Australian company Sirtex’s (OTC: SXMDF) SIR-Spheres® being the obvious analogy.
This is where a company like ADMD really stands out from the competition with its Yttrium-90 (Y-90) based radiotherapy solutions, such as the Y-90 RadioGel™ device (ruled a medical device by the FDA in 2013) which is a highly localized direct delivery technology that is injected into the tumor. Y-90 RadioGel delivers an exceptional therapeutic ratio (high degree of dose delivered to cancer tissues, relative to impact on normal tissues) thanks to Y-90’s short-range, which effectively delimits radiation impact to surrounding tissues. RadioGel promises to offer a superior therapeutic profile compared to existing solutions in the brachytherapy segment, even innovations such as Y-90 microspheres that pose significant migration risks, and thus still carry the standard risk to normal surrounding tissues.
Unlike more expensive brachytherapy industry standard isotopes such as Cesium-131, Iodine-125, or Palladium-103 (which primarily emit auger x-rays of an infinite path length, use complex/costly delivery systems, and have a half-life ranging from 9.7 to 60 days), Yttrium-90 has a very short path length of only 4mm, a half-life of just 2.7 days, and is considerably less expensive/more accessible. This means Y-90 solutions are much safer to handle for healthcare professionals, treatment times are sizably reduced, and huge cost savings can find their way to the consumer. Perhaps most importantly though, is the earlier point about how Y-90 RadioGel is not limited to a handful of tumor/cancer types, as is the case with most microsphere or seed-based brachytherapy products.
Tech Portfolio Coverage Hints at Upper Limit Potential
Not content to rest on the laurels of a brachytherapy device like RadioGel, which obliterates the migration problem and has shown in studies that greater than 99 percent of the radiation stays in the tumor, the company has also developed a new approach to so-called permanent seed brachytherapy as well. ADMD’s Y-90 Fast-Resorbable Polymer Seeds (which contain RadioGel), unlike the industry standard glass or titanium seeds (which are packed with radioactive material and then injected to the tumor site), are fully resorbable/biodegradable and leave no casing behind.
The contrast couldn’t be more apparent between these proprietary polymer seeds containing RadioGel, and standard permanent seed therapy in the typical use scenario of prostate cancer. The RadioGel-containing polymer seeds are administered via a minimally invasive procedure that only requires small-gauge needles, whereas the standard permanent seed therapy uses up to 30 large needles, which inject seeds whose casings are left behind. Put yourself in the shoes of a patient for even five seconds and the contrast becomes glaringly obvious.
ADMD has even developed a Y-90 Polymer Topical Paste product engineered for direct application to tissues after a tumor resection, where it works hard to kill off any residual tumor cells that got missed during the surgery. This is an important product due to the constant fear of cancer recurrence, which has been a PR black-eye for the oncology community, and is indeed quite devastating to brave cancer survivors. Going through all the cost, suffering, and difficulties of cancer treatment, only to have the cancer come back, is a living nightmare that is all too common among cancer patients.
The short-range beta radiation emitted by Y-90 particles offers such high therapeutic index possibilities that the products ADMD has developed could even help to gradually reshape the standards of care within the broader cancer treatment market. And brachytherapy, one of the oldest known approaches to radiotherapy, could see a big, big resurgence. The company has exclusively licensed the Y-90 polymer composite tech (which was developed at Pacific Northwest National Laboratory) from the legendary Battelle Memorial Institute, one of the top government/commercial research institutes in the world.
ADMD is On the March, Pet Oncology is the Spear Tip
The company achieved an important milestone in late February 2017 with its fourth letter in a series of communications with the FDA, wherein the company identifies skin cancer (basal cell and squamous) as the primary indication via which RadioGel will be pushed towards FDA submittal and commercialization. An excellent choice given the laborious complexities of skin cancer surgeries and their post-op complications. These issues are particularly vexing for elderly patients, who have skin that is usually significantly thinner and much less robust.
With some 3.3 million or more skin cancer patients in the U.S. alone, many of whom have more than one tumor, it is reasonable to assert that the superior therapeutic profile of ADMD’s RadioGel could see the product rapidly become the indication of choice preferred by both patients and healthcare professionals alike. Looking at the technology portfolio here and the broad range of cancer types that can be treated using ADMD’s products, it should be tantalizing to investors just how much of the roughly $113 billion global cancer therapy market the company could eventually gobble up. Particularly when one considers the 7.4 percent CAGR projections for the industry as a whole through 2021. Post-commercialization, once the word about this technology really starts getting out to consumers, ADMD could be sitting on a gold mine.
The company also released a key letter to shareholders in February, mapping the new and streamlined path forward to FDA submission, which also contained a more formal introduction of new management appointed at the end of 2016. It included the appointment of a new CEO by the Board of Directors, Dr. Michael Korenko, and the appointment of Dr. Carlton Cadwell as Chairman. It’s a serious move by ADMD to show the FDA that they are not only listening, but taking guidance as gospel.
As a prominent indicator of just how aggressive the company really is about commercialization, one need only look at its emphasis on the veterinary oncology market. This is something of an open trade secret these days in biopharma: if you want to rapid-prototype your way into human use as a novel medical device developer, on-ramp via the pet market (if you are lucky enough to be able to).
Advanced Medical Isotope Corporation’s wholly-owned IsoPet Solutions subsidiary just announced late last year in October that the first animal, a cat, had received initial treatment with the pet version of the Y-90 RadioGel. This study will generate important data and help to advance the product towards commercialization in the veterinary market, paving the way for longer-term human use approval by the FDA. This is an exciting forward vector for the company, given the Trump administration’s vow in February to massively overhaul the FDA, with an emphasis on speeding up the pace at which new drugs come to market.
Looking at just the veterinary oncology market we have a winning proposition with ADMD’s Y-90 tech portfolio, given that roughly half of all dogs and around one third of all cats will be diagnosed with cancer in their lifetime. There are around 85.8 million cats and 77.8 million dogs in the country and we now live in an age where pets are essentially bonafide members of the family. The preceding statistic should color the likely much broader incident rate of undiagnosed cancers in cats and dogs, and throw light on the comparatively much cheaper/effective radiotherapy solutions ADMD is developing. Cancer is the leading cause of mortality in cats and dogs alike, with the average radiation treatment for dogs currently costing from around $5,000 to $7,000.
People love their pets but that is a hefty price tag for the average consumer. IsoPet Solutions could place effective pet cancer treatment for a broad range of caner types well within comfortable striking distance for millions of average consumer households. Ask around, comprehensive cancer treatment for pets is simply not doable for most people today, as the average pet owner simply cannot afford to shell out that kind of capital, even for a cherished pet whom they consider a genuine member of the family. The PR upside for ADMD on this subject alone basically writes itself. As an investor, one can just imagine the publicity boon from being able to make such a boast to pet owners, as having an effective/affordable cancer treatment to save the lives of their cats and dogs.
The proven efficacy of radioisotopes for melting cancer in a localized fashion, further hyper-localized and made safer by the company in terms of impact to surrounding tissues, is an easy sell. ADMD is a very interesting play in the oncology space with some serious potential due to broad spectrum applicability of the tech, and is currently trading near the bottom of the 52-week range ($0.07 to $1.00) at approximately $0.15/share.
To take a closer look, visit https://www.isotopeworld.com and http://www.isopetsolutions.com
About QualityStocks
QualityStocks is committed to connecting subscribers with companies that have huge potential to succeed in the short and long-term future. We offer several ways for investors to find, evaluate, and learn more about investing in these companies.
- See more at: https://www.findit.com/bakcapvpfqqxwkj/RightNow/advanced-medical-isotope-corpt/78c2d202-1e7c-4280-8586-917394853a1d#sthash.fkNt7v3o.dpuf
Annual report out
THE IMPORTANCE OF CLINICAL TRIALS IN BIOTECH
March 7, 2017adminNews
THE IMPORTANCE OF CLINICAL TRIALS IN BIOTECH
Clinical trials are a critical phase of development in the field of biotechnology. It can be extremely challenging, but also highly rewarding as a product progresses from smaller, safety trials, to later stage trials involving much larger patient numbers. However, if successful at each stage, companies can find themselves increasing many multiples in value and often find themselves the target of an acquisition, or their product licensed to Big Pharma who have the marketing and sales force capabilities to distribute a potential new blockbuster product.
Understanding more about the different phases of clinical trials:
Phase I is the first trial involving humans where researchers study how the drug interacts with a healthy human subject..
Phase II is when the company attempts to prove the drug is effective against a disease target by administering the drug to patients who have the condition..
Be on the lookout for biotech companies with up and running clinical trials. Companies in Phase I or II clinical trials are a strong indication of potential future success.
UPDATES ON PROPANC HEALTH GROUP CORP CLINICAL TRIALS (PPCH)
Insiders and outsiders of the biotech world are hearing more and more about PPCH, the Australian-based biotechnology company seeking to develop new long term treatments for cancer. Propanc has made significant progress advancing towards its first human trials for their lead product, PRP.
PRP targets malignant cancer cells through multiple pathways. As a result, the company believes the product may create a lasting clinical benefit for the patient. Propanc is in the final stages of completing non-clinical studies and intends to file a clinical trial application in the UK later this year. The clinical trials will assess the safety and efficacy of their product against solid tumors. Propanc CEO, James Nathanielsz outlined its development plans for PRP, as the company intends to begin a Phase 1 human study by the end of 2017.
PPCH just announced the successful completion of the low dose group for its GLP-compliant 28-day repeat dose toxicity study. With no safety concerns in the low dose group, Propanc received approval to proceed with the middle and high dose groups from the International Animal Care & Use Committee (IACUC) in Melbourne, Australia.
The company submitted four new patents in the US, Australia, and Spain last year on the dosage and mechanism of action for its two proenzymes used in PRP, two proenzymes, trypsinogen and chymotrypsinogen. With recent approvals of intellectual property rights and patents in various regions around the world, their patents are reaching significant milestones and increasing in value.
IN OTHER BIOTECH NEWS…
According to data from S&P Global Market Intelligence, MannKind Corp. (MNKD), lost 56% of its value over the course of 2016. This drugmaker’s huge downfall was caused by the termination of its license and collaboration agreement with Sanofi for inhaled insulin product last Spring. However, the company has been working to regain some of these losses recently.
If you are attending the American Association for Cancer Research (AACR) 2017 Annual Meeting held April 1-5 in Washington D.C., look out for Affimed N.V. (AFMD). They’re a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies. They announced they’ll be presenting preclinical data for their lead candidate AFM13, the Company’s preclinical programs AFM24 and AFM26, as well as data on its MHC-peptide-targeting discovery program.
Eyegate Pharmaceuticals Inc. (EYEG) recently struck a deal with biotech giant Valeant Pharmaceuticals. The deal totals $103 million for the tiny ocular focus biotech, will see Valeant pick up the rights to Eyegate’s lead development asset in a postoperative inflammation indication, and involves both an upfront payment and a raft of milestone rooted cash injections.
The Durham, NC-based company, Novan (NOVN), is pushing on with programs in five dermatological conditions, with its lead candidate, SB204, a topical gel that targets multiple mechanisms of action for the treatment of acne vulgaris–the most common skin disease in the U.S.
Legal Disclaimer
Except for the historical information presented herein, matters discussed in this article contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. ACR Communication, LLC. which owns Microcapspeculators.com, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. ACR Communication, LLC. which owns, Microcapspeculators.com may from time to time have a position in the securities mentioned herein and may increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice. ACR Communication LLC. which owns Microcapspeculators.com may be compensated for its services in the form of cash-based compensation or in equity in the companies it writes about, or a combination of the two. For Full Legal Disclaimer Click Here.
Cure Some dogs and cats.
If that happens, stock price will explode
Stock price is doing nothing right now
What is happening?
Not today I'm afraid
Disappointing day so far
It's obvious you want to buy more
Propanc Successfully Completes Low Dose Group for GLP-Compliant 28-Day Repeat-Dose Toxicity Study
WoW target price of 0,78 - 1,57 ??????
Kaboooooom
A lot of 4999 buys since the opening
News !!!!!!
TOP BIOTECH INDUSTRY, CANCER TREATMENT COMPANIES
BACK TO HOMEPAGE
SUBSCRIBE TO RSS FEED
Top Biotech Industry, Cancer Treatment Companies
Print This Article
Share it With Friends
With a new year on the horizon and things looking up for biotech, where should one invest considering the current biotech environment?
“Cancer is a great place overall to invest in,” says health care analyst Eric Schmidt of Cowen & Co. in New York.
Many large pharmaceutical companies are bringing on their first wave of drugs to the market while others are working on second- and third-generation drugs. Be on the lookout for Propanc Health Group Corporation (PPCH) as they prepare to conduct first-in-man (FIM) studies for lead product, PRP.
“We are pleased with the progress of PRP this year, and believe we are entering an exciting growth phase for the future of the company in 2017 and beyond…”-James Nathanielsz, PPCH’s CEO Propanc is developing new cancer treatments for patients suffering from pancreatic, ovarian and colorectal cancers and have announced their plans 2017. lead product, PRP, is a solution for daily intravenous administration of pancreatic proenzymes typsinogen and chymotrypsinogen. This could transform the way the world treats cancer patients.
2016’s in R&D
Prepared and submitted four new patents relating to the dosing, anti-cancer effects and mechanisms of the two proenzymes against various cancers in Australia, Spain and the United States.
Executed a manufacturing agreement with AmatsiQBiologials in Belgium beginning the process for the finished productPRP for human use.
Completed 14-day, dose range toxicity study in rats determining maximum for further studies.
Developed an enzyme linked immunosorbent assay (ELISA) method.
Developed and validated a new IR (infrared) dye-labelled detection method for typsinogen and chymotrypsinogen.
Commenced the in-life phase of a GLP-compliant, 28-day repeat dose-toxicity study for PRP in rats, which is expected to help define the safe starting dose in advanced cancer patients for the first-in-man studies.
2016’s Success Indicate the Following 2017
Completion of the GLP-compliant, 28-day repeat-dose toxicity study in rats for PRP.
Finished product manufacture and release of an intravenous formulation of PRP for clinical trials.
Validation of the ELISA assay for the analysis of PRP in human blood plasma to measure the distribution over time in patients.
Preparation and submission of an investigational medicine product dossier (IMPD) and clinical trial application (CTA) for PRP in the UK, for FIM studies.
Commencement of FIM studies for PRP, targeting advanced cancer patients (solid tumors)
“Our expectation is, as Propanc becomes a clinical stage biopharmaceutical company, there will be opportunities to grow and expand our pipeline, as well as working towards generating revenue through partnering our lead product, PRP, which we have already initiated preliminary discussions for, and expect to further these discussions as we generate clinical trial data.” -James Nathanielsz, PPCH’s CEO
ADV MEDICAL ISO (ADMD) CEO Michael K. Korenko Acquires 700,000 Shares of Stock
Posted by Cynthia Vaughn on Jan 19th, 2017 // No Comments
ADV MEDICAL ISO logoADV MEDICAL ISO (OTCMKTS:ADMD) CEO Michael K. Korenko purchased 700,000 shares of the business’s stock in a transaction dated Tuesday, January 17th. The shares were purchased at an average cost of $0.15 per share, with a total value of $105,000.00. Following the purchase, the chief executive officer now directly owns 130,000 shares in the company, valued at $19,500. The transaction was disclosed in a filing with the SEC, which is available through this hyperlink.
ADV MEDICAL ISO (OTCMKTS:ADMD) traded up 0.0000% on Thursday, hitting $0.1599. The stock had a trading volume of 2,300 shares. ADV MEDICAL ISO has a one year low of $0.07 and a one year high of $1.00. The stock has a 50-day moving average of $0.01 and a 200-day moving average of $0.01. The company’s market cap is $3.20 million.
About ADV MEDICAL ISO
Advanced Medical Isotope Corporation, formerly Savage Mountain Sports Corporation, is a radiation oncology focused medical device company. The Company is engaged in the development of yttrium-90 (Y-90)-based brachytherapy devices for the treatment of non-resectable tumors. Brachytherapy uses radiation to manage cancerous tumors by placing a radioactive isotope inside or next to the treatment area.
Propanc Completes Pivotal 28 Day Toxicokinetic Study for Lead Product PRP
DOWNLOAD AS PDF October 25, 2016
MELBOURNE, AUSTRALIA -- (Marketwired) -- 10/25/16 -- Propanc Health Group Corporation (OTCQB: PPCH) ("Propanc" or "the Company"), an emerging healthcare company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, today announced it completed a 28 day toxicokinetic study to support determination of a safe starting dose in patients as the Company progresses towards clinical trials in 2017 for its lead product, PRP. PRP is a solution for intravenous administration of pancreatic proenzymes trypsinogen and chymotrypsinogen. All animals involved in the study appeared to be doing well, no issues were reported and plasma levels were not impaired over time.
Data from the GLP (Good Laboratory Practice) compliant, 28 day repeat dose toxicokinetic study will form the basis of a clinical trial application in the UK. The purpose of the study was to evaluate the toxicokinetic parameters of PRP following repeated, daily intravenous tail vein administration in rats and to evaluate distribution and bioavailability of the test articles over an extended period. Furthermore, the pharmacological properties and bioavailability of the treatment before and after repeat exposure were also evaluated.
Studies of this type are an important part of the development process for new therapeutic agents prior to clinical testing in humans and was discussed in detail at a recent scientific advice meeting with the Medicines and Healthcare Products Regulatory Agency (MHRA), UK, earlier this year. Data generated from this study will define conditions for a planned 4-week regulatory GLP compliant toxicology study commencing mid-November 2016 with results expected early 2017.
In addition, the Company is on target to file a second orphan medicinal product designation (OMPD) application for ovarian cancer with the European Medicines Agency (EMA) this month. Furthermore, similar orphan drug designation applications will be filed for pancreatic and ovarian cancers with the U. S. Food and Drug Administration (FDA) later this year. As well as satisfying the criteria for OMPD status for ovarian cancer in Europe, management believes that PRP will satisfy the criteria for orphan drug designation for both indications in the United States, where prognosis for patients diagnosed with these diseases are poor and few treatment options are available.
"We are making excellent progress completing these pivotal studies for PRP," said James Nathanielsz, Propanc's Chief Executive Officer. "Preclinical efficacy is well established and the safety studies are pivotal because it provides the rationale for a safe starting dose for patient trials. In addition, we are finalizing our OMPD application for ovarian cancer which we will submit to the EMA very soon. This is the second indication where we are seeking this status in Europe, the first being pancreatic cancer. We will then target the US for both indications. We believe these are important milestones for the future development of PRP."
To be added to the email distribution list, please email PPCH@kcsa.com with "Propanc" in the subject line.
About Propanc:
Propanc is developing new cancer treatments for patients suffering from pancreatic, ovarian and colorectal cancers. We have developed a formulation of anti-cancer compounds, which exert a number of effects designed to control or prevent tumors from recurring and spreading throughout the body. Our products involve or employ pancreatic proenzymes, which are inactive precursors of enzymes. In the near term, we intend to target patients with limited remaining therapeutic options for the treatment of solid tumors. In future, we intend to develop our lead product to treat (i) early stage cancer and (ii) pre-cancerous diseases and (iii) as a preventative measure for patients at risk of developing cancer based on genetic screening. For more information, visit: www.propanc.com.
swamp,
Stock price doesn't lie.
I have been away for a while and kept my shares.
When and what to expect the following months?
reverse split also here?
like ADMD
situation now 1 million shares * 0.0017 = 1700 usd
after monday 10000 * 0.17 = 1700 usd
I rather hit 1 dollar in the first situation ....
gone is the profit.....
Propanc Health Group Corp (OTCMKTS:PPCH) Might Be A Preclinical Diamond In The Rough
By Chris Sandburg / in Biotech & Pharma, Momentum Stocks, Stocks / on Friday, 07 Oct 2016 04:13 AM / 0 Comment / 27 views
diamond
We’re all about trying to uncover early stage biotech companies with big upside potential, and there’s one in particular that looks interesting right now. It has taken a bit of a beating year to date, and currently trades 75% off highs. It’s heading into a pivotal development phase, however, and we could see a flurry of catalysts across the next 12 months – catalysts which, if they fall in favor of the company, could easily spark a longer-term upside reversal. The company we are talking about is Propanc Health Group Corp (OTCMKTS:PPCH).
Preclinical biotechs don’t generally get that much attention from wider markets. It is often difficult to get an investor excited about a technology or treatment before it has reached the clinic and started trials in humans. Propanc is already starting to generate a bit of buzz, however, based on the unique mechanism of action of its lead (and only) clinical asset – PRP. We took a look at the drug in question, and sat in on a recent presentation from company scientists, and we think it’s well worth a look despite its pre-clinical credentials.
The company is an oncology focus, and it currently trades for a market capitalization of a little over $10 million. The asset in question, PRP, is looking as though it is going to target ovarian cancer as an initial lead indication (we are basing this assumption on comparative analysis of preclinical data) but it’s not confirmed as yet.
So what is the mechanism of action that everybody is getting excited about?
To understand, it’s worth touching on a generalization before we get into the specifics. Tumors have standard cancer cells, and these are the cells that traditional therapies (chemotherapy etc.) target. However, deep within a tumor, there are what are called cancer stem cells. Standard treatment very rarely reaches these cells, and as such, even after a patient undergoes a course of therapy, the dormant cancer stem cells generally remain. That’s important point number one. Important point number two is that there is a process called EMT, which is essentially the cells transitioning and changing function. It’s a standard process, and in healthy cells, it applies to things like wound healing and tissue repair. In cancer stem cells, however, it causes the cells to activate and starts a transitional process, which eventually sees them migrate away from the tumor in question. This migration forms the basis of the metastasis associated with cancer spreading.
So, with that out of the way, things become pretty simple to explain. PRP reverses EMT’s effect on cancer stem cells, and as they transition away from the primary tumor, PRP converts them into healthy epithelial cells. It’s essentially turning cancer cells back into healthy cells, and this is what is exciting about it. It’s (theoretically) non-toxic, or at least nowhere near to the degree of current standard of care, and could be applied to a wide range of cancers outside the initial ovarian target.
We could talk about the science behind this one all day, and perhaps at some point we will put forward a follow-up in which we go into to things in a little more detail. In order to avoid this dragging on, however, let’s move away from the science and look at the company and its catalysts.
Pre-clinical efficacy is pretty well established, and the company is currently undertaking a 28 day safety toxicokinetic study that will form the basis of an investigational new drug application for the asset. Completion of this study is expected before the end of this year, and we should get results late this quarter. We see these results as a near-term catalyst.
A recent press release also addressed the initiation of manufacturing of the product, and once we have some degree of confirmation that the manufacturing process is standardized and effective (we expect this early first quarter next year) then we should see some speculative volume moving ahead of an IND application submission and, beyond that, clinical initiation.
It’s worth noting here that this is not without its risks. Pre-clinical biotechnology can be a bit of a minefield, and that’s why the more risk-averse investors will generally avoid it altogether. However, every so often, something stands out, and we think we’ve got just that with Propanc.
Growing Consensus the Most Effective Way to Beat Cancer is through a Combination of Drugs
MELBOURNE, Australia, June 15, 2016 /PRNewswire/ -- Propanc Health Group Corporation (OTCQB: PPCH) ("Propanc" or "the Company"), an emerging healthcare company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, today announced a current wave of excitement has reached the oncology sector, as reported by Peter Evans, journalist for the Times, UK, claiming that the financial rewards for an effective medicine, or even one that might one day become effective, are "astronomical". In his article, he highlights a growing number of companies are looking to expand their portfolio with potential new drug combinations as a way to "finally beat cancer". This could have significant implications for innovative new approaches, like Propanc's lead product, PRP.
Life-changing Biotech
Innovative therapies are keeping patients alive for longer – and offering long-term revenue streams, he predicts. The area causing the most excitement at the recent American Society of Clinical Oncologists (ASCO) conference is immunotherapy, a class of treatments where the body's immune system is activated to attack cancer. However, there is a growing consensus the way to finally beat cancer is through combinations of drugs, attacking cancerous cells on a number of fronts, thus increasing the chances of killing it.
"My scientific colleagues and I believe a cancer stem cell targeting therapy, which reduces chemo-resistance and supports immune function could become a significant addition to the treatment process," said Dr. Julian Kenyon, Propanc's Chief Scientific Officer. "PRP is going to be a part of many different cancer combinatorial regimes, which is why we're keen to follow up on the immuno-biological aspects of PRP in future trials, as connections with strategic partners are likely to flow from that. For instance, activated proenzymes (enzymes) are known to reduce TGF-Beta levels in the blood, a key marker responsible for preventing the body's immune system from attacking cancer cells. We've also confirmed scientifically that PRP suppresses genes relating to chemo-resistance, thus making standard therapies effective where previously they might not have worked. All of this suggests PRP could become an attractive proposition for those interested in both increasing and enhancing their oncology portfolio."
The Company recently announced they have engaged the services of two advisory firms in North America, Maxim Group LLC and Partner International Inc., to explore potential strategic partnering opportunities for the company's lead product, PRP.
"Rest assured we have been watching the recent ASCO conference and paying close attention to the oncology players who may be interested in our innovative approach to managing tumor spread," said James Nathanielsz, Propanc's Chief Executive Officer. "In the meantime, we'll continue to advance our science and look towards clinical trials as soon as possible."
The Company aims to fast track the development of proenzyme related oncology products into clinical trials initially for pancreatic and ovarian cancers, followed by colorectal cancer. According to Global Analyst Reports, the combined world market for pancreatic, ovarian and colorectal cancers are expected to reach over $12 billion by 2020.
About Propanc:
Propanc is developing new cancer treatments for patients suffering from pancreatic, ovarian and colorectal cancers. We have developed a formulation of anti-cancer compounds, which exert a number of effects designed to control or prevent tumors from recurring and spreading throughout the body. Our products involve or employ pancreatic proenzymes, which are inactive precursors of enzymes.
In the near term, we intend to target patients with limited remaining therapeutic options for the treatment of solid tumors. In future, we intend to develop our lead product to treat (i) early stage cancer and (ii) pre-cancerous diseases and (iii) as a preventative measure for patients at risk of developing cancer based on genetic screening. For more information, visit: www.propanc.com
Forward-looking Statements:
Certain of the matters discussed in this announcement involve risks and uncertainties including, without limitation, those regarding the Company's ability to establish and maintain the proprietary nature of its technology through the patent process, its ability to license from others patents and patent applications, if necessary, to develop certain products, its ability to implement its long range business plan for various applications of its technology, and its ability to enter into agreements with any necessary marketing and/or distribution partners for purposes of commercialization. This is not a solicitation to buy or sell securities and does not purport to be an analysis of the company's financial position. See Propanc's most recent Quarterly Report on Form 10-Q and related 8K filings
MELBOURNE, Australia, June 13, 2016 /PRNewswire/ -- Propanc Health Group Corporation (OTCQB: PPCH) ("Propanc" or "the Company"), an emerging healthcare company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, today announced an update on the significant progress of PRP development activities towards First-in-Man studies since the successful completion of the Medicines and Healthcare Products Regulatory Agency (MHRA) meeting in London, UK, April 25th.
IR-dye labelled trypsinogen and chymotrypsinogen clearance over a 24 hour period
Since the meeting, the Company initiated a number of activities relating to quality and manufacturing of raw materials and finished drug product fill for clinical trials, and non-clinical development of PRP. Non clinical activities include pharmacokinetic (measurement of movement and distribution of drug in the blood) method development of PRP in blood plasma and an upcoming formal 28 day toxicology study (including a toxicokinetic arm, designed to determine the relationship between the level of exposure of PRP in the blood and its toxicity).
These activities include:
Detailed discussions held with Quality Manufacturers regarding the purification of starting materials, characterization of the API's (Active Pharmaceutical Ingredients) and future planned upscaling of GMP (Good Manufacturing Practice) manufacture of API's, as well as finished product manufacture of PRP in sufficient quantities to cover planned Phase I patient trials;
Commencement of method development with an analytical services laboratory in the UK, developing the scientific methods required to characterize the raw materials prior to and completion of the purification process of API materials for manufacturing;
Initiation of a validation study for an IR (infrared) dye-labelled detection method for both, trypsinogen and chymotrypsinogen measuring bio-distribution in blood plasma and tissue samples for an upcoming 28 day toxicokinetic study. Importantly, results so far indicate a faster clearance rate than expected and there is strong support for daily dosing of both compounds;
Development work for an ELISA (enzyme linked immunosorbent assay) conducted with a research institution in Melbourne, Australia, to generate polyclonal antibodies against the two proenzymes, trypsinogen and chymotrypsinogen, as well as the two enzymes activated from the proenzymes, for clinical trials. Initial antibody titers are very encouraging.
A recent test facility audit successfully completed at vivoPharm Australia in preparation for the upcoming 28 day repeated dose toxicology study to be conducted in the third quarter this year in Melbourne, Australia.
Sufficient quantities of raw materials of trypsinogen and chymotrypsinogen sourced from the Company's current supplier and soon to be released for the upcoming 28 day study and planned API purification process and finished product manufacturing of PRP.
"Over the last six months, Propanc's development team has worked extremely hard to progress PRP to a stage where a constructive discussion could be held with the MHRA to define our development pathway," said James Nathanielsz, Propanc's Chief Executive Officer. "I am pleased to say we had a successful meeting and are working hard to complete the activities necessary to support a clinical trial application. So far, it appears we are on track to complete this goal early next year and I am delighted with the level of commitment and effort shown by our Development team. As I mentioned previously, we are presently transforming into a clinical stage biopharmaceutical company and I expect more exciting developments to unfold this year as we progress towards first-in-man studies for PRP."
In further news, the Company has commenced preparing orphan drug designation (ODD) applications for treatment of pancreatic and ovarian cancers to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) during the second half of 2016. Upcoming licensing discussions with strategic partners are also expected to take place later this year.
The Company aims to fast track the development of proenzyme related oncology products into clinical trials initially for pancreatic and ovarian cancers, followed by colorectal cancer. According to Global Analyst Reports, the combined world market for pancreatic, ovarian and colorectal cancers are expected to reach over $12 billion by 2020.
About Propanc:
Propanc is developing new cancer treatments for patients suffering from pancreatic, ovarian and colorectal cancers. We have developed a formulation of anti-cancer compounds, which exert a number of effects designed to control or prevent tumors from recurring and spreading throughout the body. Our products involve or employ pancreatic proenzymes, which are inactive precursors of enzymes.
In the near term, we intend to target patients with limited remaining therapeutic options for the treatment of solid tumors. In future, we intend to develop our lead product to treat (i) early stage cancer and (ii) pre-cancerous diseases and (iii) as a preventative measure for patients at risk of developing cancer based on genetic screening. For more information, visit: www.propanc.com
Forward-looking Statements:
Certain of the matters discussed in this announcement involve risks and uncertainties including, without limitation, those regarding the Company's ability to establish and maintain the proprietary nature of its technology through the patent process, its ability to license from others patents and patent applications, if necessary, to develop certain products, its ability to implement its long range business plan for various applications of its technology, and its ability to enter into agreements with any necessary marketing and/or distribution partners for purposes of commercialization. This is not a solicitation to buy or sell securities and does not purport to be an analysis of the company's financial position. See Propanc's most recent Quarterly Report on Form 10-Q and related 8K filings.
Life-changing Biotech
Photo - http://photos.prnewswire.com/prnh/20160610/377834
Logo - http://photos.prnewswire.com/prnh/20160429/361516LOGO
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/propanc-provides-shareholder-update-on-prp-development-activities-300282921.html
SOURCE Propanc Health Group Corporation
Released June 13, 2016
Friday, June 03, 2016
Advanced Medical Isotope Corporation to Present at the LD Micro Invitational
[ACCESS WIRE]
LOS ANGELES, CA / ACCESS WIRE / June 3, 2016 / Advanced Medical Isotope Corporation (or "AMI") (OTC: ADMD), a late stage development company engaged in the development of brachytherapy devices for therapeutic applications today Announced That it will be presenting at the 6th annual LD ??Micro Invitational on Tuesday, June 7th at 12:30. James C. Katzaroff, Founder, CEO and Chairman will be giving the presentation and meeting with investors.
The conference will be held at the Luxe Sunset Bel Air Hotel and will feature 195 companies in the small / micro-cap space.
View Advanced Medical Isotope Corporation's profile here: http://www.ldmicro.com/profile/ADMD
Profiles powered by LD Micro - News Compliments or Access Wire
About Advanced Medical Isotope Corporation
Advanced Medical Isotope Corporation (ADMD) is a late-stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for the treatment of non-resectable tumors. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The Company intends to outsource material aspects of manufacturing, distribution, sales and marketing for its products in the United States and to enter into licensing arrangements outside of the United States, though the company will Evaluate its alternatives before finalizing its plans. For more information, please visit our website, www.isotopeworld.com .
About LD Micro
LD Micro was founded in 2006 with the sole purpose of being an independent resource in the microcap space. What started out as a newsletter highlighting unique companies HAS trans formed into an event platform hosting several at influential conferences Annually (Invitational, Summit, and Main Event).
In 2015, LDM Launched the first pure microcap index (the LDMi) to Exclusively providence intraday information on the entire sector. LD will continuous to providence valuable tools for the benefit of everyone in the small and microcap universe.
For Those interested in attending, please contact David Scher at david@ldmicro.com or visit www.ldmicro.com for more information.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify thesis statements by the use of the words "may," "will," "should," "plans," "Expects, "" Anticipates, "" continue, "" estimates, "" projects, "" intends, "and similar expressions. Forward-looking statements involvement risks and uncertainties That could cause results to differ materially from Those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, zoals by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in are completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, short passages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
CONTACT:
Advanced Medical Isotope Corporation
James C. Katzaroff, CEO
1021 N Kellogg
Kennewick WA 99336
509-736-4000
SOURCE: Advanced Medical Isotope Corporation at LD Micro
MELBOURNE, Australia, May 31, 2016 /PRNewswire/ -- Propanc Health Group Corporation (OTCQB: PPCH) ("Propanc" or "the Company"), an emerging healthcare company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, today announced that the Company has engaged the services of Maxim Group LLC and Partner International Inc. to initiate potential strategic partnering discussions for the Company's lead product, PRP.
Propanc Health Group Logo
PRP, a combination of two proenzymes trypsinogen and chymotrypsinogen, is a novel, targeted therapy for the treatment and prevention of metastatic cancer. Scientific evidence has shown potent effects against cancer stem cells, inducing these cells to differentiate (transform) into a less malignant, or dormant state, thus rendering them benign. Cancer stems cells represent the final frontier, as they are responsible for metastasis and invasion, causing the cancer to return and spread. They are also resistant to standard treatment options.
"Our lead product, PRP, represents an exciting and novel method to control the threat of resistant tumors which if left untreated, can ultimately lead to patient death," said James Nathanielsz, Propanc's Chief Executive Officer. "What is also important, is that PRP targets cancer stem cells, but leaves healthy stem cells alone. This means it is less toxic than standard treatments. We believe PRP could become a welcome addition to the treatment process for many aggressive cancer types, like pancreatic and ovarian cancers, where patient prognosis is often poor, when diagnosed. We therefore think this will be an attractive, novel therapy for those Pharmaceutical, Biotech or Mid-Tier Specialty Companies serious about treating this killer disease."
Maxim Group LLC is a leading full-service investment banking, securities and wealth management firm headquartered in New York. The Firm provides a full array of financial services including investment banking; private wealth management; and global institutional equity, fixed income and derivative sales & trading, equity research and prime brokerage services to a diverse range of corporate clients, institutional investors and high net worth individuals.
Partner International is a leading corporate development firm with offices in the US, Canada, Australia and Switzerland, whose highly experienced team with all therapeutic areas, including drugs, diagnostics, vaccines and medical devices, has led to both buy- and sell-side transactions in markets around the world. President and CEO, Joanne Ball-Gautschi said "We are very pleased to be representing Propanc. PRP is a very exciting breakthrough in cancer therapeutics and we expect significant response from the industry."
The Company aims to fast track the development of proenzyme related oncology products into clinical trials initially for pancreatic and ovarian cancers, followed by colorectal cancer. According to Global Analyst Reports, the combined world market for pancreatic, ovarian and colorectal cancers are expected to reach over $12 billion by 2020.
Propanc Engages Two Advisory Firms to Identify Strategic Partnering Opportunities
DOWNLOAD AS PDF May 31, 2016
We are all screwed?
What is happening?
but why denied twice?
Propanc Conducts Successful Scientific Advice Meeting with the MHRA
? Download as PDF
May 02, 2016
The Company confirms Preclinical and Clinical Development Pathway for PRP
MELBOURNE, Australia, May 2, 2016 /PRNewswire/ -- Propanc Health Group Corporation (OTCQB: PPCH) ("Propanc" or "the Company"), an emerging healthcare company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, announced today a successful meeting was held with the UK Medicines and Healthcare Products Regulatory Agency, confirming the formal preclinical requirements to commence a first-in-man study with the Company's lead product, PRP. As a result, the Company hopes to submit a clinical trial application (CTA) for late stage cancer patients with solid tumors in the UK, early 2017.
Life-changing Biotech
The Company discussed the quality development of PRP, the design of a non-clinical GLP (Good Laboratory Practice) safety toxicology study and the design and response criteria for the planned Phase I study with PRP.
"The discussion with the MHRA was highly productive and confirms our development plans for PRP," said James Nathanielsz, Propanc's Chief Executive Officer. "Significant steps forward with our scientific research, including elucidating PRP's mechanism of action and potent effects against cancer stem cells, as well as important preclinical development activities over the past twelve months, have placed us in a position where we intend to commence patient trials early next year. Whilst this is a reflection of our team's hard work, our immediate attention now turns towards commencing this important non-clinical toxicology study and the GMP (Good Manufacturing Practice) production of PRP for clinical trials. We are excited about entering this next phase of development and believes this a genuine milestone as the Company transforms into a clinical stage development company."
A submitted draft of the meeting minutes is currently being reviewed and a final response from the MHRA will be confirmed in the next few weeks.
As a next step in the development program of PRP, management will now turn its attention towards applying for orphan drug designation for pancreatic and ovarian cancers in the United States and Europe. If achieved, the Company will receive market exclusivity for up to 7 to 10 years, ongoing regulatory advice and discounted fees on regulatory submissions.
"Achieving orphan drug designation will add significant value to our Company and cannot be underestimated. We are excited about the potential qualification of PRP for orphan drug status and plan to submit the applications in the near future," said Mr. Nathanielsz.
The Company aims to fast track the development of proenzyme related oncology products into clinical trials initially for pancreatic and ovarian cancers, followed by colorectal cancer. According to Global Analyst Reports, the combined world market for pancreatic, ovarian and colorectal cancers are expected to reach over $12 billion by 2020.
About Propanc:
Propanc is developing new cancer treatments for patients suffering from pancreatic, ovarian and colorectal cancers. We have developed a formulation of anti-cancer compounds, which exert a number of effects designed to control or prevent tumors from recurring and spreading throughout the body. Our products involve or employ pancreatic proenzymes, which are inactive precursors of enzymes.
In the near term, we intend to target patients with limited remaining therapeutic options for the treatment of solid tumors. In future, we intend to develop our lead product to treat (i) early stage cancer and (ii) pre-cancerous diseases and (iii) as a preventative measure for patients at risk of developing cancer based on genetic screening. For more information, visit: www.propanc.com
NEWS !!!!!