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$PMCB PharmaCyte Biotech Clears Major Milestone on Path to FDA Clinical Trial
NEW YORK, NY--(Marketwired - May 05, 2016) - PharmaCyte Biotech (OTCQB: PMCB) has now reached a point in its life cycle where it is ready to start working with the U.S. FDA to get the company's Phase 2b clinical trial in advanced pancreatic cancer underway. Let that sink in for a moment. PharmaCyte's Chief Executive Officer, Kenneth L. Waggoner, has taken up the mantle to move the company's signature technology, Cell-in-a-Box®, to the clinic. And now, three short years later, he has the small biotech on the doorstep of what could be an eye-opening clinical trial to treat pancreatic cancer patients.
According to the American Cancer Society's cancer statistics for 2016, pancreatic cancer is the third leading cause of cancer-related deaths in the United States, and it's one of the few cancers for which survival has not improved substantially over nearly 40 years. But help could be on the way. After PharmaCyte announced last week that the live-cell encapsulation facility where its Cell-in-a-Box® capsules are produced is now current Good Manufacturing Practices or cGMP-compliant, the company cleared what was a major milestone on the way to a clinical trial and is now closer than ever to taking on the challenge of improving the lives of pancreatic cancer patients.
These are truly exciting times at PharmaCyte, and with the cell encapsulation facility now cGMP-compliant, the company can set its sights on first requesting a pre-IND (Investigational New Drug application) meeting with the FDA to discuss the design of its upcoming clinical trial.
This pre-IND meeting will be crucial to developing a relationship with the FDA and getting the necessary answers and guidance moving forward that will allow PharmaCyte to submit its formal IND to the FDA. The pre-IND meeting and the IND submission to the FDA are the next two major milestones for PharmaCyte and its investors.
With the encapsulation facility now ready for the production of clinical trial material, let's look at the trial design that PharmaCyte has announced for its Phase 2b clinical trial:
PharmaCyte's pancreatic cancer therapy consists of placing microcapsules containing genetically engineered live cells near the blood supply to the pancreas. The cancer prodrug ifosfamide is then given at one-third the normal dose. When the blood carries the chemotherapy drug to where the capsules have been placed, activation of the drug takes place right at the source of the cancer instead of in the patient's liver, which eliminates any side effects in these patients.
The trial will be a multi-site trial held in both the United States and Europe. It will also be an open-label trial in which the patients will be randomized between two study groups. The trial has been designed to meet a clear unmet medical need that exists for a particular group of pancreatic cancer patients.
The randomization ratio of patients between the two study groups will be 1:1 (an equal number of patients will be randomly assigned to the capecitabine + radiation group and the PharmaCyte pancreatic cancer therapy group).
Only patients who have locally advanced, non-metastatic, inoperable cancer and whose tumors no longer respond after 4-6 months of treatment with either the widely used Abraxane® + gemcitabine combination therapy or FOLFIRINOX, will be eligible for the trial. These patients are usually treated with the combination of the chemotherapy drug capecitabine + radiation, but this treatment is only marginally effective and is quite toxic for the patients.
Study sites under consideration in the U.S. include the Mayo Clinic in Scottsdale, Arizona, the Beth Israel Deaconess Cancer Center in Boston, the Dana-Farber Cancer Institute also in Boston, the Baylor Cancer Center in Dallas, Texas, Cedars-Sinai Medical Center in Los Angeles, as well as sites in Germany and Spain.
It is believed that 84 patients will be required to complete the study, although fewer may be required based upon the data developed during the trial.
Unlike in earlier clinical trials using PharmaCyte's pancreatic cancer therapy where patients received only two cycles of therapy with ifosfamide, multiple cycles of ifosfamide will be given to those being treated with PharmaCyte's pancreatic cancer therapy. This will continue until the patients' tumors no longer respond to PharmaCyte's therapy or until treatment-related toxicity accumulates to unacceptable levels.
And the best news of all for investors heading into these exciting times is that PharmaCyte has been awarded the Orphan Drug designation by both the U.S. FDA and the European Medicines Agency (EMA). This designation means that the company's pancreatic cancer therapy will have complete protection and market exclusivity for years to come. After PharmaCyte's therapy is approved for marketing by these two regulatory agencies, they will enjoy 7 years of market exclusivity in the United States and 10 years of protection in the European Union.
PharmaCyte's CEO also recently stated that the company's pancreatic cancer therapy qualifies for 12 years of data exclusivity because it is considered a "biologic" as outlined by the Biologics Price Competition and Innovation Act (BPCIA).
So, as the company marches headlong into a Phase 2b clinical trial in the U.S. and Europe with a built in "hard stop" about half way through the trial to review the data, there is no better time than the present to get excited about this small biotechnology company and what could very well be a significant contribution to the treatment of pancreatic cancer.
About Stock Market Media Group
Stock Market Media Group is a Content Development IR firm offering a platform for corporate stories to unfold in the media with research reports, corporate videos, CEO interviews and feature news articles. This article was written based upon publicly available information. PharmaCyte Biotech has not endorsed this article, and Stock Market Media Group was not compensated for its production.
Stock Market Media Group may from time to time include our own opinions about the companies, their business, markets and opportunities in our articles. Any opinions we may offer about any of the companies we write about are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice, or construed or interpreted as research. Any investment decisions you may make concerning any of the securities we write about are solely your responsibility based on your own due diligence. Our publications are provided only as an informational aid, and as a starting point for doing additional independent research. We encourage you to invest carefully and read the investor information available at the web site of the U.S. Securities and Exchange Commission at: www.sec.gov, where you can also find all of PMCB's filings and disclosures. We also recommend, as a general rule, that before investing in any securities you consult with a professional financial planner or advisor, and you should conduct a complete and independent investigation before investing in any security after prudent consideration of all pertinent risks.
We are not a registered broker, dealer, analyst, or advisor. We hold no investment licenses and may not sell, offer to sell or offer to buy any security. Our publications about any of the companies we write about are not a recommendation to buy or sell a security.
For more information: www.stockmarketmediagroup.com.
$PMCB One step closer to curing diabetes
A human cell line genetically engineered to produce, store and release insulin in response to blood sugar levels in the human body could eliminate the need for daily injections for insulin-reliant diabetics.
Developed by UTS's Professor Ann Simpson and her team at the UTS Centre for Health Technologies, these insulin producing "Melligen" cells show promise as a possible cure for type 1 diabetes. This month, the team secured US patent protection for the cell line from the US Patent and Trademark Office.
"My team and I are extremely pleased that the US patent for the Melligen cells has been granted," says Simpson. "This takes us a step closer to releasing diabetics from the need to inject insulin daily and, more importantly, protecting them from the debilitating complications of the disease such as blindness, kidney failure and cardiovascular problems."
The group is now working with US clinical stage biotechnology company PharmaCyte Biotech to commercialise the research.
PharmaCyte specialises in the development of targeted treatments for cancer and diabetes using its signature live cell encapsulation technology. This technology, known as Cell-in-a-Box, is a key process in the commercialisation of the Melligen cell as a revolutionary treatment.
"This is a culmination of many years' work by our group and we look forward to working with PharmaCyte's Diabetes Consortium to utilise the Cell-in–a-Box technology to encapsulate the cells for preclinical trials aimed at curing diabetes," says Simpson.
"We anticipate that the capsule technology will protect the Melligen cells from the body's immune response that normally destroys foreign tissue, allowing the Melligen cells to be transplanted into humans."
PharmaCyte's Chief Executive Officer, Kenneth L Waggoner, says, "We at PharmaCyte consider ourselves to be very fortunate in having secured the exclusive world-wide licence to use the Melligen cells to develop a treatment for diabetes.
"If we are successful in this effort, it will bring to fruition the many years of research that have been conducted by Professor Simpson and her colleagues at UTS in developing these remarkable cells. Importantly, we are very pleased that Professor Simpson will be assisting PharmaCyte in this endeavour as a member of our International Diabetes Consortium.
"For the millions of people worldwide who suffer from a disease of epidemic proportions, our treatment could relieve them of the onerous daily requirements for insulin administration and dietary restrictions and offer a life free from the very serious and even life-threatening complications associated with diabetes."
With the World Health Organization attributing more than 1.5 million deaths to diabetes in 2012 and more than 422 million adults suffering from the disease in 2014, the development has the potential to impact millions of lives.
The cell line already has patent protection from the European counterpart to the US Patent and Trademark Office and the patent has been validated in France, Switzerland, Great Britain, Ireland, Germany, Spain, Denmark, Italy and the Netherlands.
http://m.medicalxpress.com/news/2016-05-closer-diabetes.html
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