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PharmaCyte Biotech Successfully Completes Final Manufacturing Run of Clinical Trial Product
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 its partner, Austrianova Singapore (Austrianova), has successfully completed the second and final GMP manufacturing run to produce PharmaCyte’s clinical trial product. The product is now ready for “release testing.” The data from the “release testing” of both manufacturing runs will be included in an Investigational New Drug application (IND) and submitted to the U.S. Food and Drug Administration (FDA) to support PharmaCyte’s planned clinical trial in patients with locally advanced, inoperable pancreatic cancer (LAPC).\n\n\nThe capsules, which are fully filled with genetically modified live cells, were immediately put into PharmaCyte’s clinical trial syringes and then frozen. Austrianova has shipped a representative sample of the frozen syringes to third-party laboratories in Europe to undergo “release testing” related to the “safety” of the product. Austrianova will conduct “release testing” in-house related to the “functionality” of the encapsulated cells.\n\n\nPharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “Today is a great day at PharmaCyte. We have cleared what was a major hurdle for us and have completed our most impactful milestone to date. Successfully completing two manufacturing runs is a milestone that has now been met as we progress toward our submission of an IND to the FDA so we can begin our clinical trial in LAPC.\n\n\n“Our GMP consultant, cGMP Validation, has informed us that while two successful manufacturing runs are not required by the FDA to request a Phase 2b clinical trial, it could go a long way in demonstrating to the FDA that our manufacturing process is robust and reproducible – manufacturing qualities that are highly embraced by the FDA.”\n\n\nTo 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: https://www.PharmaCyte.com/Cancer\n\n\nAbout PharmaCyte Biotech\n\n\nPharmaCyte Biotech, Inc. (PharmaCyte) is a biotechnology company deve...