NEW YORK, NY--(Marketwired - January 24, 2017) - Ten years ago the National Cancer Institute (NCI) recognized the rise in pancreatic cancer deaths and called for the development of better treatments. The NCI encouraged developers to design more clinical trials that don't use the chemotherapy drug gemcitabine as part of their treatment. PharmaCyte Biotech (OTCQB: PMCB) is on the doorstep of doing just that -- developing a treatment that doesn't use gemcitabine, and instead the company has designed a clinical trial that will actually go head to head with gemcitabine.
In that NCI-sponsored "State of the Science" meeting ten years ago, the organization called for "a need to abandon the mindless propagation of the 'gemcitabine vs. gemcitabine + your drug here' design used for over a decade." PharmaCyte will use its advanced, inoperable pancreatic cancer therapy, which consists of the company's signature live-cell encapsulation technology, Cell-in-a-Box®, plus low doses of the FDA-approved chemotherapy drug ifosfamide, in its upcoming clinical trial where it will go head to head with gemcitabine in order to address an unmet medical need.
Eli Lilly's cancer drug Gemzar® or gemcitabine has been the single-agent "gold standard" for the treatment of pancreatic cancer since the FDA approved it back in 1996. It wasn't until the FDA approved Celgene's cancer drug Abraxane® combined with gemcitabine in 2013 that pancreatic cancer patients had a better option than using gemcitabine alone. The unmet medical need that PharmaCyte expects to address in its clinical trial is for those patients who no longer see any benefit from using Abraxane® combined with gemcitabine.
Eli Lilly, Celgene and PharmaCyte all have something in common with their respective pancreatic cancer therapies -- leading pancreatic cancer expert Dr. Daniel Von Hoff of Translational Drug Development (www.td2inc.com). Dr. Von Hoff was involved as the Principal Investigator in the development of both gemcitabine for Eli Lilly, and Abraxane® combined with gemcitabine for Celgene. Both therapies became the "gold standard" for advanced pancreatic cancer upon FDA approval.
Dr. Von Hoff and his firm Translational Drug Development (TD2) will now help PharmaCyte with its pancreatic cancer therapy in an upcoming clinical trial that he helped design along with Dr. Manuel Hidalgo, who is the Chief of the Division of Hematology-Oncology at Harvard Medical School's Beth Israel Deaconess Medical Center and who will serve as the Principal Investigator in PharmaCyte's upcoming clinical trial, and Dr. Matthias Löhr of the Karolinska Institute in Stockholm, Sweden.
Dr. Von Hoff helped to get approval for Celgene's Abraxane-gemcitabine combination fast-tracked by showing the FDA that there is an urgent need for better treatments for advanced pancreatic cancer, and there is a real opportunity that PharmaCyte's therapy could also be fast-tracked if the company can produce data that is similar or better than the data produced in two earlier independent clinical trials using the therapy.
It is interesting to note that in those earlier clinical trials, PharmaCyte's advanced, inoperable pancreatic cancer therapy provided better results than both gemcitabine alone and the Abraxane-gemcitabine combination.
When comparing current median survival time numbers, based upon recent data, we find that gemcitabine offers 6.7 months of median survival time for advanced pancreatic patients, the Abraxane-gemcitabine combination, on the other hand, offers 8.5 months, while PharmaCyte's therapy offers 11 months, albeit using far fewer overall patients.
The results also included a 100% increase for PharmaCyte's therapy in the one-year survival rate as compared to historical data for gemcitabine, while the Abraxane-gemcitabine combination saw a 59% increase in one-year survival rate over gemcitabine alone.
Also, in those earlier clinical trials, the effects of PharmaCyte's therapy on tumor size were measured at 10 and 20 weeks after treatment. And, in those patients that were treated using Cell-in-a-Box® plus low doses of ifosfamide, not a single patient saw any further growth of their tumors during this period. Two of the 14 patients showed a partial response (more than a 50% reduction in tumor size), 12 patients showed stable disease (tumor reduction of 50-125%) and two patients showed a minor response (tumor reduction of 24-50%). In two patients, their inoperable tumors were reduced enough in size and orientation by PharmaCyte's treatment that those tumors became operable.
In PharmaCyte's upcoming clinical trial, patients who are enrolled in the trial must have inoperable pancreatic cancer that has not yet spread from the pancreas where it first started to any other place in the body. These patients must also have tumors that no longer respond to the combination chemotherapy treatment of Abraxane® plus gemcitabine after they've been on that treatment for a period of between 4 and 6 months.
Patients will be randomly distributed into two groups. The patients in Group 1 will receive PharmaCyte's pancreatic cancer therapy; whereas, those patients in Group 2 will receive treatment with gemcitabine alone.
Unlike in the earlier clinical trials where patients received only two doses of ifosfamide, the company's new trial design calls for multiple cycles of ifosfamide to be given to those patients 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.
Also, in the upcoming clinical trial, PharmaCyte will have the advantage of using Imaging Endpoints for radiologic imaging. Imaging Endpoints will provide its advances in radiology science to detect, track and confirm that PharmaCyte's therapy is working. The use of radiologic imaging has become an essential component for the assessment of treatment activity in any treatment plan involving solid tumors, especially in pancreas cancer. And with even more imaging opportunities scheduled in the new trial design, the likelihood of detecting tumor shrinkage and other biologic activity is greatly enhanced.
PharmaCyte recently had a pre-IND meeting with the U.S. FDA to discuss the company's clinical trial, its therapy for pancreatic cancer and its trial design. PharmaCyte has announced it will be hosting a shareholder conference call on February 7, 2017, to discuss the meeting it had with the FDA.
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