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®, announced today that its clinical trial product, CypCapsTM, is still stable and active after completing the 18-month timepoint of ongoing product stability testing required by the United States Food and Drug Administration (FDA).
When stored at -80oC, this means the product has a shelf life of at least 18 months. After two years of storage at -80oC, the next scheduled time point will be the ongoing testing. Analysis The unfrozen CypCaps product passed all of the stipulated tests after 18 months of storage at -80oC, including cell viability, enzyme activity, cell potency, pH, label check, capsule appearance, and integrity. This continuing stability study began before the Company’s IND was submitted to the FDA.
PharmaCyte’s cancer treatment entails encasing genetically altered human cells that convert an inactive chemotherapeutic medication into an active, cancer-killing version. First, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close to the tumor site as possible in pancreatic cancer. Then, the ifosfamide is delivered to the place where the circulatory system has implanted the encapsulated cells. When ifosfamide passes through the capsules’ pores, the living cells operate as a “bio-artificial liver,” activating the chemotherapy medicine at cancer’s location.