LAGUNA HILLS, Calif.– 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®, announced today the first test results of the biocompatibility studies of its CypCaps™ clinical trial product candidate. These results were from an “In Vitro Complement Activation Study of Empty Cellulose Sulphate Capsules,” the same capsules PharmaCyte uses in its treatment for pancreatic cancer.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “A number of studies are currently ongoing by independent, third-party CROs on the biocompatibility of our CypCaps pancreatic cancer product candidate and its components. We are pleased to report that we have received the results from the first of these studies showing that, as expected, the capsule material does not activate a major line of the human body’s innate defense – the complement system. This is just one of the biocompatibility studies that are being performed and, in the coming weeks, we expect that the results of other studies will become available.”
The complement system consists of multiple proteins, approximately 30 of which are circulating blood proteins that work together to promote immune and inflammatory responses. The complement system’s principal role is to help identify, destroy, and remove foreign pathogens such as bacteria and viruses, as well as damaged cell materials (for example, cells and proteins).
The objective of the ISO 10993-4: 2017 (E) compliant study was to evaluate the complement activation potential of empty cellulose sulphate capsules when mixed with normal human serum complement under in vitro test conditions. The study was performed by a third-party GLP laboratory. That laboratory concluded that empty cellulose sulphate capsules did not activate the complement system under defined experimental conditions based on the results of the study. These results were also supported by statistical comparisons.