PharmaCyte Biotech Successfully Completes Three-Month Stability Study

PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, announced today that it has successfully completed the three-month product stability testing that is required by the U.S. Food and Drug Administration (FDA) for its CypCaps and CypCaps passed all of the FDA-required tests. This is the final product that will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed three-month stability study, “We are pleased to announce that our Cell-in-a-Box encapsulated cell product CypCaps has passed all of the FDA-required tests for the first three-months of a 24-month stability study. This is part of an ongoing study to determine the shelf life of the CypCaps final product that the FDA requires for all medical products. The data will be included in our IND. All future longer-term shelf life analyses, such as the next one at six months post-production, will be reported to the FDA but is not required for PharmaCyte to submit an IND.”

As based in the ICH guidelines, regulatory agencies around the world, including the FDA, require a shelf-life determination for all medical products. Living products, like cell therapies such as CypCaps, as well as live vaccines etc., are particularly sensitive and more prone to inactivation over time, so it is especially important to determine the shelf-life for these products.

A battery of tests was performed on CypCaps that had been frozen post-production for three months of storage at -80C. Samples were thawed to show that the cells inside the CypCaps were still alive and functional as well as free of infectious agents. Some of these tests were performed by Austrianova (cell count, biological activity of the cells, capsule integrity, label integrity), whereas others (sterility, pH measurement) were performed by contract labs.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: https://www.PharmaCyte.com/Cancer

About PharmaCyte Biotech

PharmaCyte Biotech, Inc. (PharmaCyte) is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed.