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PharmaCyte Biotech Successfully Completes 24-Month Stability Study of Its Clinical Trial Product Candidate
LAS VEGAS--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and
About this update from Pharmacyte Biotech, Inc.
[{"type":"text","content":" LAS VEGAS--(BUSINESS WIRE)--\nPharmaCyte 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 it has successfully completed a 24-month product stability study required by the U.S. Food and Drug Administration (FDA) for its clinical trial product candidate, CypCaps™. The significance of this timepoint is that CypCaps has now demonstrated that it has a shelf life of at least 24 months when stored at -80oC.\n\nPharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed 24-month stability study, “While we continue to establish a maximum shelf life for our clinical trial product candidate, CypCaps, reaching the 24-month timepoint is highly significant in allowing PharmaCyte to store a biologic at -80oC. We demonstrated that frozen CypCaps maintain their viability, enzymatic activity and cell potency after 2 years of storage at -80oC in a cryopreserved state. This is a major milestone not only for PharmaCyte but also for the cell therapy field.”\n\nAfter 24 months storage of the Cell-in-a-Box encapsulated cell product, CypCaps, at -80oC, the product was thawed and analyzed for cell viability, enzyme activity and cell potency as well as being examined for pH, label integrity, capsule appearance, capsule integrity and container closure integrity.\n\nNotably, over the entire 24-month period, there was no significant change in the number and viability of the encapsulated cells, or, most importantly, in the biological activity that is key to activating the anti-cancer mechanism PharmaCyte uses for its cancer therapy. The successfully completed stability study was initiated prior to the submission of the company’s IND to the FDA, and the information and data obtained from the study will form part of the updated package of information that will be provided to the FDA, together with data from additional studies requested by this regulatory agency.\n\nThis formal study, performed under GMP conditions, confirms previous laboratory data generated by PharmaCyte’s partner, Austrianova, showing cell viability and activity of a similar Cell-in-a-Box cell encapsulation product upon storage in the frozen state for over 6 years.\n\nThis data is remarkable and stands in stark...