On December 2, 2020 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, reported that it has successfully completed the nine-months product stability testing that is required by the U.S. Food and Drug Administration (FDA) for its CypCaps final product, which will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer (Press release, PharmaCyte Biotech, DEC 2, 2020, View Source [SID1234572092]).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed nine-month stability study, "The product stability studies of our CypCaps product initiated prior to submitting our Investigational New Drug application (IND) to the FDA are still proceeding smoothly while we are answering the questions raised by the FDA following our IND submission. We are also starting additional studies designed to provide information that the FDA has requested, which are mainly focused on the handling of the CypCaps product in the clinic, and on additional animal data to add to the data that we have already supplied in our IND package.

"The ongoing stability study is designed to determine the shelf life of the Cell-in-a-Box encapsulated cell product, CypCaps, frozen at -80°C, and I am pleased to report that the nine-month time point was recently reached and that CypCaps passed all of the necessary tests, including cell viability, enzyme activity and cell potency, pH, label check, capsule appearance and integrity. This nine-month data, as well as all future longer-term time points of the shelf life analyses, such as the next milestone, the 12-month time point, will be reported to the FDA as an update to our submitted IND."

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