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PharmaCyte Biotech Addresses Submission of IND and Recent FDA-Required Testing
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 the latest in its series of Q&A articles that are conducted with some of the key management members of PharmaCyte’s research and development team related to its upcoming clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).\n\n\nThis interview-style Q&A article with Dr. Gerald W. Crabtree, PharmaCyte’s Chief Operating Officer, aims to address the company’s recent FDA-required tests and the submission process of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA). Dr. Crabtree has spent almost 50 years working in academia and biotech and pharmaceutical companies, with the majority of that experience being in the development of drugs and treatments for cancer. He has supervised and coordinated the development of multiple drug candidates, prepared clinical protocols, investigator brochures, monographs and research and review articles.\n\n\nA highlight of Dr. Crabtree’s professional career was his tenure as Director of Project Planning and Management (Oncology and Immunology) at Bristol-Myers Squibb (BMS) from 1990 to 1997. While at BMS, Dr. Crabtree established and directed a department that monitored and coordinated the development of all oncologic and immunologic drugs from initial discovery through regulatory approval within BMS and served as Project Manager for the development of the major anticancer agent, Taxol®, the leading product candidate under development at BMS at that time. Taxol® ultimately became a multi-billion-dollar drug for BMS and is still widely used in combination with other drugs to treat a variety of cancers.\n\n\nCurrently PharmaCyte is awaiting the testing results from its pyrogenicity test, an FDA-required test, that has been discussed in the past but that wasn't part of the release testing. Can you tell us what this test is and why this test is important?\n\n\nDr. Crabtree: “In short, the U.S. FDA wants to know if the Cell-in-a-Box® capsules that we use in our treatment for LAPC have any fever-inducing properties, and a pyrogenicity test is how we provide this necessary data to the FDA.\n\n...