PharmaCyte Biotech Inc (PMCB)

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LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCBD), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that the production and shipping of test materials and study plan designs for the biocompatibility studies requested by the U.S. Food and Drug Administration (FDA) have been completed.The “CypCaps” product represents a refinement of the original encapsulated cells that were successfully tested in previous clinical trials. In order to show comparability, the FDA requested that standard biocompatibility studies be performed by a Contract Research Organization (CRO) in accordance with regulatory requirements. Study plans have been finalized and the Company’s most time-consuming study has already commenced and is ongoing. These studies required the production of additional capsule material for testing, and this effort has been completed by Austrianova. Some of the material also had to be prepared and treated in accordance with the requirements of the tests. This work has also been completed and the materials, both treated and non-treated, have been shipped to and received by, the CRO.PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “The commencement of the most rate-limiting study represents yet another major step for complying with the FDA’s requirements. As our work continues to advance to produce the required data to satisfy the FDA and move toward an open IND, our expectation is to complete the FDA’s list of requirements in the Fourth Quarter of this year.“Additionally, as we continue our work to achieve an open IND, we have also continued our plan to make ourselves more attractive to the investment community and uplist to Nasdaq. We believe the reverse stock split, which was recently enacted, will assist the Company in pursuing additional financing activities and other strategic transactions to support the development of our product candidates. We believe this is a necessary step before the Company’s common stock can be listed on a national stock exchange like Nasdaq, which is our expectation. Nasdaq is requiring the Company to trade above $4.00 for 10 trading days before we can uplist.”