On September 14, 2020 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical-stage 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 six-month product stability testing that is required by the U.S. Food and Drug Administration (FDA) for its clinical-trial ready product known as CypCaps (Press release, PharmaCyte Biotech, SEP 14, 2020, View Source [SID1234565105]). This product will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) for which PharmaCyte submitted an Investigational New Drug application (IND) to the FDA in early September.
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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed six-month stability study, "Our IND submission is now with the FDA for review, but independent of the IND we are working on our ongoing storage stability study to determine the shelf life of the Cell-in-a-Box encapsulated cell product. It will be kept stored frozen at -80oC throughout the entire duration of the stability study. The six-month time point of the study was recently reached, and we are pleased to report that CypCaps has passed all of the FDA-required tests. With each successful time point reached, this means our final product has proven that it can remain functional when frozen and stored up to that time point.
"This is a continuation of ongoing 24-month stability study to demonstrate the shelf life of our final clinical trial product that the FDA requires for all medicinal products. These six-month data, as well as all future longer-term shelf life analyses, such as the next twelve months post-production shelf life evaluation, will be reported to the FDA but this information does not require PharmaCyte to modify its submitted IND."
ICH guidelines, as well as regulatory agencies around the world, including the FDA, require that shelf life data needs to be determined and provided for any new medicinal product. The functionality of cell-based therapies such as CypCaps, as well as live vaccines etc., are particularly prone to loss of viability, and thus activity, during storage. This necessitates detailed shelf-life determination studies for such products.
A whole range of predefined and agreed tests have been performed on CypCaps that were unfrozen after six months of storage at -80oC. These studies include determinations of the number of cells, cell viability, biological activity of the cells, integrity of the capsules, sterility and pH. It also includes verifying that the labels are still securely adhering to the frozen syringes and are still legible. These tests were performed either by Austrianova (cell count, biological activity of the cells, capsule integrity, label integrity) or by its affiliated subcontractor (sterility, pH measurement).
The recently reported Container Closure Integrity test that demonstrates that the syringes are properly sealed and that the contents of the syringes have not been contaminated is also formally part of the product stability testing. Thus, the CypCaps product passed all of the required tests at this six-month time point.
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