Therapy Areas: Diabetes
PharmaCyte Biotech Commences First Phase of Two-Phase Pig Study
21 July 2022 - - US-based biotechnology company PharmaCyte Biotech, Inc. (NASDAQ: PMCB) has commenced the pilot phase of its two-phase pig study, the company said.

The pig study is the last of several requirements PharmaCyte has complied with related to the requests from the US Food and Drug Administration to lift the clinical hold on PharmaCyte's planned Phase 2b clinical trial for locally advanced, inoperable pancreatic cancer.

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.

PharmaCyte Biotech, Inc. is a biotechnology company developing cellular therapies for cancer, diabetes, and malignant ascites based upon a proprietary cellulose-based live-cell encapsulation technology known as "Cell-in-a-Box."

This technology is being used as a platform upon which therapies for several types of cancer, diabetes and malignant ascites are being developed.


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