PharmaCyte Biotech Finalizes Pancreatic Cancer Treatment for U.S. FDA Approval to Begin Clinical Trial

NEW YORK, NY, Dec. 11, 2019 (GLOBE NEWSWIRE) -- PharmaCyte Biotech (OTCQB: PMCB) has a clinical trial product, a clinical trial protocol, including a clinical trial design, a Principal Investigator, and the company is ready to present its treatment for locally advanced, inoperable pancreatic cancer (LAPC) to the U.S. FDA in an effort to secure approval to begin a Phase 2b clinical trial in LAPC.  

LAPC is a hard-to-treat disease that leaves patients with very little hope after first-line therapies, Abraxane plus gemcitabine or FOLFIRINOX, no longer offer any benefit to this patient population.  The company’s Chief Operating Officer, Dr. Gerald W. Crabtree, said of this group of patients, “Here we have a cadre of patients that are virtually untreatable.  They respond to a certain degree to first-line treatment and then can no longer respond, and there they sit with very little option for further response.”

However, hope, in the form of a unique live-cell encapsulation technology, could very well be on the way for patients who are stricken with LAPC if the FDA approves PharmaCyte’s Investigational New Drug application (IND).  Pancreatic cancer is usually only controllable through removal by surgery and only if found before it has spread to other parts of the body or other organs.  PharmaCyte’s treatment, which consists of its signature live-cell encapsulation technology, Cell-in-a-Box, plus low doses of the chemotherapy drug ifosfamide, has already proven in earlier Phase 1 and Phase 2 clinical trials that it can be effective in doing just that—shrinking tumors to the point that they become operable. 

Commenting on those earlier trials, PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “What’s unique about our therapy is looking back at the earlier clinical trials, patients that had stage 4 metastatic pancreatic cancer had their tumors go from inoperable to operable.”

PharmaCyte plans to conduct a Phase 2b clinical trial with a treatment that uses genetically engineered cells to treat cancer.  Those cells have been engineered to produce an enzyme, which is normally produced in the patient’s liver, that will convert ifosfamide from its inactive form to its active form.  Essentially what patients with LAPC can expect from PharmaCyte’s treatment is that it diverts the conversion of ifosfamide from the patient’s liver, where normal conversion takes place, to the 300 Cell-in-a-Box capsules, which contain a total of about 6.6 million live cells located in the blood supply to the pancreas and whose job it is to “wake up” the non-active drug right at the site of a patient’s tumor.