On December 28, 2021 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 36-month stability study of the cells from its Master Cell Bank (MCB) (Press release, PharmaCyte Biotech, DEC 28, 2021, View Source [SID1234597810]). These cells will be encapsulated and then used to treat locally advanced, inoperable pancreatic cancer (LAPC). This stability study is one of the items that the U.S. Food and Drug Administration (FDA) requires PharmaCyte to complete for its clinical trial product, CypCaps, in an effort to lift the FDA’s clinical hold. This means that the cells used to produce the CypCaps have a shelf life of at least 36 months when stored in a vapor phase of liquid nitrogen. Vapor phase temperature for liquid nitrogen is between -140°C and -180°C.
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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed 36-month stability study, "The ongoing study to determine the maximum shelf life of the MCB cells has reached another important milestone. Cells from our MCB successfully completed the required tests to prove that the cells are stable and remain active after being stored frozen for 36 months in a vapor phase of liquid nitrogen.
"Analysis of the cells from our MCB after 36 months showed that the cells passed all of the specified tests, including cell viability, identity testing, sterility, enzyme activity and cell potency as well as pH, label check and appearance of the cells.
"This study will continue in order to determine the maximum shelf life of the cells from our MCB. It is distinct from the other ongoing stability study on the shelf life of our CypCaps that continue to be stored at approximately -80°C. While the storage temperatures are different for the MCB cells and the CypCap cells, the tests for both stability studies are the same."
This ongoing stability study was initiated prior to the submission of PharmaCyte’s Investigational New Drug Application (IND) to the FDA. The information and data obtained from this stability study and other studies will form part of PharmaCyte’s Complete IND Submission of information that PharmaCyte will provide to the FDA to have the clinical hold lifted.
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