PharmaCyte Biotech Finalizes Design of Pancreatic Cancer Clinical Trial and Identifies Trial Sites under Consideration

PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted therapies for cancer and diabetes using its live-cell encapsulation technology, Cell-in-a-Box^®, today announced the final design of its clinical trial for patients with advanced pancreatic cancer. The clinical trial design was developed with Translational Drug Development (TD2), America’s premier oncology Contract Research Organization, as well as with renowned pancreatic cancer specialists consulting with PharmaCyte.
According to the news:

Major factors in the overall trial design are:

• The clinical trial will be international (United States, Europe and possibly Australia), multi-site, open-label and randomized.
• Study sites under consideration in the United States include the Mayo Clinic in Scottsdale, Arizona, the Beth Israel Deaconess Cancer Center and the Dana-Farber Cancer Institute both in Boston, Massachusetts, the Baylor Cancer Center in Dallas, Texas, the City of Hope Cancer Center in Los Angeles, California, and sites in Germany and Spain.
• 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).
• As many as 84 patients will be required to complete the study, although fewer may be required based upon the data developed during the trial.
• Only patients who have locally advanced, non-metastatic, inoperable cancers and whose tumors no longer respond after 4-6 months of treatment with either the nab-paclitaxel (Abraxane^®) + gemcitabine or FOLFIRINOX regimens will be eligible for the study.
• Unlike the earlier clinical trials using PharmaCyte’s pancreatic cancer therapy where patients received only two doses of 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.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated:

The trial is designed to determine if PharmaCyte’s pancreatic cancer treatment (the combination of micro-capsules that contain genetically modified human cells which convert the cancer prodrug ifosfamide into its “cancer-killing” form at one-third the normal dose) can satisfy a clear unmet medical need that exists for patients with locally advanced, inoperable pancreatic cancer who no longer respond to the current standard of care. Most of these patients are initially treated with the combination of nab-paclitaxel (Abraxane^®) plus gemcitabine or the four-drug combination known as FOLFIRINOX. When these patients’ tumors no longer respond to treatment with these regimens, the next standard of care offers little to no benefit. It is then that these patients are often treated with the combination of the anticancer drug capecitabine plus radiation therapy. However, this combination is only marginally effective in stopping the progression of the disease. In PharmaCyte’s clinical trial, our pancreatic cancer therapy will be compared “head to head” with the capecitabine/radiation combination to demonstrate that it is clearly superior in treating these patients while maintaining a superior quality of life during the therapy.