On March 22, 2022 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, reported 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 (Press release, PharmaCyte Biotech, MAR 22, 2022, View Source [SID1234610609]). 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.

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PharmaCyte’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."

After 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.

Notably, 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.

This 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.

This data is remarkable and stands in stark contrast with data obtained after cryopreservation of alginate encapsulated cells where one study showed viability after 2 weeks storage (Nicola Cagol, Walter Bonani, Devid Maniglio, Claudio Migliaresi, Antonella Motta (2018) Effect of cryopreservation on cell-laden hydrogels: comparison of different cryoprotectants. Tissue Eng. Part C Methods 24:20-31) and another using alginate encapsulated islets showed viability when thawed after 4 weeks storage in a frozen state (Greg G Kojayan, Antonio Flores, Shiri Li, Michael Alexander, and Jonathan RT Lakey (2019) Cryopreserved alginate-encapsulated islets can restore euglycemia in a diabetic animal model better than cryopreserved non-encapsulated islets. Cell Medicine 11: 1-6). Another study using cryopreserved cardiosphere-derived cells encapsulated in alginate-poly-L-lysine-alginate microcapsules showed viability of the cells after being revived 60 days after storage in a frozen state (Paz-Artigas L, Ziani K, Alcaine C, Báez-Díaz C, Blanco-Blázquez V, Pedraz JL, Ochoa I, Ciriza J. (2021) Benefits of cryopreservation as long-term storage method of encapsulated cardiosphere-derived cells for cardiac therapy: A biomechanical analysis. Int J. Pharm. 607:121014).

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: View Source