Business
PharmaCyte Biotech Announces Final Major Study for IND Submission Has Begun
LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer
About this update from Pharmacyte Biotech, Inc.
[{"type":"text","content":" LAGUNA HILLS, Calif.--(BUSINESS WIRE)--\nPharmaCyte 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®, announced today that the final major study required by the U.S. Food and Drug Administration (FDA) for the submission of PharmaCyte’s Investigational New Drug application (IND) has been initiated.\n\n\nThe study, referred to as the “Stability Study” is a rolling two-year study to demonstrate how the frozen clinical trial product manufactured by Austrianova Singapore (Austrianova) for patients with locally advanced, inoperable, pancreatic cancer (LAPC) performs over time after being frozen for certain periods of time and then thawed and tested for functionality. While the study will continue for 2 years, the FDA requires 3 months of stability data to be included in the IND for its submission.\n\n\nThe tests for the Stability Study started approximately 3 months (the first time point in the 2-year study) from the issuance of the Certificate of Analysis for the second successful manufacturing run and will continue for 24 months. Data from the balance of the Stability Study will be provided to the FDA as the data becomes available.\n\n\nThe Stability Study consists of many of the same tests that were performed as “release testing” that enabled Austrianova to issue to PharmaCyte a Certificate of Analysis for the second successful manufacturing run of the two back-to-back successful runs.\n\n\nVarious tests are taken at one or more of the following time points: month 0, 3, 6, 9, 12, 18 and 24. Month 0 represents the “release testing” for the Certificate of Analysis for the second manufacturing run that PharmaCyte previously announced earlier this year. For example, label integrity takes place on months 0, 3, 6, 9, 12, 18, and 24, while sequencing for the transgene marker takes place on months 0, 6, 12, and 24.\n\n\nThe parameters for testing are: (i) Identity (Assay: label integrity, polymerase chain reaction and sequencing for a transgene marker); (ii) Purity (Assay: appearance post thaw, pH, capsule integrity post-thaw and cultured 3 days) (iii) Viable Cell Number (Assay: determined by cell size); (iv) Potency (Assay: resorufin enzymatic activity) and (v) Integrity (Assay: container-closure int...