LAS VEGAS– PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer, diabetes, and malignant ascites using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that it has commenced the pilot phase of its two-phase pig study. The pig study is the last of several requirements PharmaCyte has complied with related to the requests from the U.S. Food and Drug Administration (FDA) to lift the clinical hold on PharmaCyte’s planned Phase 2b clinical trial for locally advanced, inoperable pancreatic cancer (LAPC).
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, explained, “As part of the Investigational New Drug Application process in preparation for our planned clinical trial in LAPC, the FDA requested data in a large animal, such as a pig, which allows for assessment of safety and distribution of CypCaps™ following infusion using the clinical route of application, devices, and procedures.
“The study will be conducted in two phases. The first phase, which began today, is a short pilot study in two pigs. The objective of this pilot study is to assess microcatheter-based delivery of CypCaps in the pancreatic arterial system. Volume of dose, number of CypCaps, and treatment location will be evaluated using imaging and histology. Also, the CypCaps used in the study will contain radiopaque microspheres, which will be evaluated to track the movement of the CypCaps.
“The data obtained from the pilot study will allow us to finalize the full-scale pig study protocol, which will involve 90 pigs. We will then present the protocol to the FDA in our planned Type A meeting which will provide us an opportunity to interact with the FDA to receive guidance on this and several other outstanding issues relating to the clinical hold. Subject to any FDA-suggested modifications to the protocol, we are fully prepared to carry on with the full-scale study. We feel that this strategy will provide the greatest likelihood for ultimate success.”
The pilot study will involve two 90-pound Yorkshire pigs. They will receive a single intra-arterial injection of 100 CypCaps into the pancreatic arterial system through a microcatheter. Fluoroscopy will be used to qualitatively evaluate parameters such as vascular anatomy, treatment site suitability, and acute deployment characteristics. Over the course of a week, the animals will be clinically observed, given health and incision site checks, and body weight and condition will be scored.
At the conclusion of the clinical phase, whole blood and serum will be analyzed, and tissue will be collected including the pancreas and adjacent areas and CT imaged to evaluate potential spillover of the CypCaps containing radiopaque microspheres. After CT imaging is performed, various tissue sections will be histologically evaluated by a board-certified veterinary pathologist. Light microscopy will be used to examine collected tissues to evaluate for any adverse effects associated with implantation of the CypCaps. Evaluation of pancreatic samples will include the presence of microspheres, necrosis, fibroplasia, fibrosis, inflammation, mineralization/ossification, and evidence of vascular injury. Light microscopy of additional tissues will be reviewed to assess for adverse effects associated with treatment, including thrombosis, necrosis, inflammation, and presence of embolic material.
Both phases of the pig study are being conducted by CBSET, Inc., located in Lexington, Massachusetts.
