On April 1, 2021 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 twelve-months product stability testing required by the U.S. Food and Drug Administration (FDA) for its CypCaps final clinical trial product (Press release, PharmaCyte Biotech, APR 1, 2021, View Source [SID1234577508]). This product will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer upon the FDA lifting the clinical hold on PharmaCyte’s Investigational New Drug Application (IND).
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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed twelve-month stability study, "We are pleased that our CypCaps product successfully completed all of the required stability tests and that the product has now shown itself to be stable and active after being stored for 1 year at -80oC. The study will continue in order to determine the maximum shelf life of the CypCaps product. It should be noted that this data is exceptional for a product of this kind."
As reported previously, the ongoing stability study is designed to determine the shelf life of the Cell-in-a-Box encapsulated cell product, CypCaps, stored frozen at -80oC. Upon analysis after 12 months in storage at -80oC, the unfrozen CypCaps product passed all of the specified tests, including cell viability, enzyme activity and cell potency as well as pH, label check, capsule appearance, and integrity. This twelve-month data, as well as all future longer-term time points of the shelf life analyses, such as the next time point to be evaluated after 18-months of storage at -80oC, will be reported to the FDA. This ongoing stability study was initiated prior to the submission of the company’s IND to the FDA, and the information and data will form part of the package of information together with data from additional studies requested by the FDA.
In a survey of European biotech/biomedical companies developing advanced therapeutic medicinal products (i.e., products containing living cells like CypCaps), shelf life issues were reported to be one of the major challenges that such products face (ten Ham et al., 2018, Molecular Therapy: Methods & Clinical Development vol. 11, pp121-130). Laboratory data on non-GMP produced encapsulated cells have suggested that the shelf life of Cell-in-a-Box products stored at -80oC is even longer than 1 year.
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