PharmaCyte Biotech, Inc. (NASDAQ: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 its clinical trial product, CypCaps™, remains stable and active at 18 months after completing the 18-month timepoint of ongoing product stability testing required by the U.S. Food and Drug Administration (FDA). This means that the product has a shelf life of at least 18 months when stored at -80oC. The next scheduled timepoint in the ongoing testing will be after 2 years of storage at -80oC.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed 18-month timepoint in its ongoing stability study, “We are pleased to announce these extended stability conditions, which will be included in our updated package of information that we provide to the FDA with the goal of lifting the clinical hold on our Investigational New Drug application (IND). This is an important development and enables simpler distribution and more flexibility at our clinical trial sites in the U.S. for our planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer should the FDA grant us an open IND.”
Analysis after 18 months in storage at -80oC, the unfrozen CypCaps product passed all the specified tests, including cell viability, enzyme activity, cell potency, pH, label check, capsule appearance and integrity. This ongoing stability study was initiated prior to the submission to the FDA of the Company’s IND. The information and data from the stability study will form part of the updated package of information that PharmaCyte will provide to the FDA, together with data from additional studies requested by the FDA.
As noted in a recent review article in “Frontiers in Medicine” by Meneghel and colleagues, stable cryopreservation is a key element in the successful delivery of live cell-based therapies. Meneghel J, Kilbride P and Morris GJ (2020) Cryopreservation as a Key Element in the Successful Delivery of Cell-Based Therapies—A Review. Front. Med. 7:592242. doi: 10.3389/fmed.2020.592242
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