NEW YORK, NY--(Marketwired - May 05, 2016) - PharmaCyte Biotech (
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:
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.
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