PharmaCyte Biotech, Inc., a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, has announced that it has successfully completed the Container Closure Integrity (CCI) test that is required by the U.S. Food and Drug Administration (FDA) for its CypCaps™ product and has passed the FDA-required test. This is the final FDA-required test on the product that will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed test, “It is with great enthusiasm that we announce our Cell-in-a-Box® encapsulated cell product CypCaps™ has passed the CCI test. This test is a component of the 24-month stability study. As with the test results we announced earlier this month, the CCI test is part of the ongoing study to determine the shelf life of the CypCaps™ final product that the FDA requires for all medical products. The data from the CCI test will be included in our IND. All future longer-term shelf life analyses, such as the next CCI test at the one-year post-production time period, will be reported to the FDA but is not required for PharmaCyte to submit its Investigational New Drug application (IND).”
As explained previously, regulatory agencies around the world, including the FDA, require a shelf-life determination for all medical products. Living products, like cell therapies such as CypCaps™, as well as live vaccines etc., are particularly sensitive and more prone to inactivation over time, so it is especially important to determine the shelf-life for PharmaCyte’s clinical trial product.
The FDA specifically required a CCI test be run on PharmaCyte’s clinical trial product and that the data from the CCI test be included in PharmaCyte’s IND.