PharmaCyte Biotech’s Pancreatic Cancer Therapy Passes Critical FDA-Required Tests as Countdown to IND Submission Begins

NEW YORK, NY, Jan. 27, 2020 (GLOBE NEWSWIRE) -- PharmaCyte Biotech (OTCQB: PMCB) announced that its clinical trial product, which will be employed during the company’s upcoming Phase 2b clinical trial to treat locally advanced, inoperable pancreatic cancer (LAPC), has passed each of the U.S. Food and Drug Administration’s (FDA) required “release tests” for safety and functionality.  With a clinical trial product that has proven to be safe and functional, PharmaCyte is now “on-the-clock” for its submission of an Investigational New Drug application or “IND” package to the U.S. FDA requesting a Phase 2b clinical trial in LAPC at trial sites throughout the United States.

In a series of 10 “release tests” over two batches of the company’s clinical trial product for a total of 20 “release tests,” PharmaCyte’s signature live-cell encapsulation technology, Cell-in-a-Box, performed admirably and proved to be both safe to place into humans in a clinical trial, and to function properly.  During the tests, the more than 20,000 genetically modified live cells that fully fill each Cell-in-a-Box capsule were functioning as expected after being manufactured, placed into syringes, frozen, thawed and then tested for enzymatic activity, cell viability, and biologic activity among a host of other tests.

And now that “release testing” has ended successfully, Austrianova will issue 2 Certificates of Analysis to PharmaCyte—1 for each manufactured and tested batch of the company’s clinical trial product.  Additionally, Austrianova will turn over all of the completed batch records to PharmaCyte from both production runs and the subsequent “release testing.”  The data generated from these tests are necessary information that must be entered into the company’s IND application. 

PharmaCyte has methodically taken extra steps to position the company for a greater chance at success once the IND is submitted to the FDA.  One such step is the manufacture and testing of two batches of its clinical trial product, which was requested by cGMP Validation, the company taking responsibility for releasing the clinical trial product into the U.S. for use in PharmaCyte’s upcoming clinical trial.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commenting on manufacturing a second batch of the company’s clinical trial product, said, “Our GMP consultant, cGMP Validation, has informed us that while two successful manufacturing runs are not required by the FDA to request a Phase 2b clinical trial, it could go a long way in demonstrating to the FDA that our manufacturing process is robust and reproducible – manufacturing qualities that are highly embraced by the FDA.”