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PharmaCyte Biotech Receives Certificates of Analysis and Batch Records for its Clinical Trial Product in Pancreatic Cancer
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 it has received the Certificates of Analysis and the records from both batches of its clinical trial product manufactured by Austrianova Singapore (Austrianova). As previously reported, both batches of the company’s clinical trial product have undergone and passed all of the necessary “release tests” required by the U.S. Food and Drug Administration (FDA).\n\n\nPharmaCyte has engaged cGMP Validation to review the batch records and the Certificates of Analysis to ensure that they are complete and that they comply with FDA requirements. This is a significant milestone in preparing the documentation for the Investigational New Drug application (IND) PharmaCyte plans to submit to the FDA to commence a Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).\n\n\nPharmaCyte is also working with Facet Life Sciences (Facet), its experienced regulatory and development services organization, to prepare and submit the IND to the FDA. Facet will now begin work with cGMP Validation to populate those modules of the IND that provide detailed information on the release testing and how the clinical trial product was manufactured and tested. This process involves a complex analysis of hundreds of pages of detailed technical information related to the manufacturing and testing of PharmaCyte’s clinical trial product.\n\n\nPharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “We are pleased to have received the Certificates of Analysis and now have access to the batch records from both manufacturing runs. This is a significant step forward. We have been waiting on the Certificates of Analysis to commission important next steps in order to complete the IND and related matters. We now have certification from Austrianova that our product has met the required release testing to demonstrate that our clinical trial product “functions” as it should and is “safe” to use in an FDA clinical trial\n\n\n“In the coming days, there will be considerable work between our team and Austrianova to make sure everything we have received from Austrianova is cGMP compliant an...