PharmaCyte Biotech, Inc. (NASDAQ:PMCB) is a biotechnology company whose focus is on developing cellular therapies for cancer, diabetes, and malignant ascites utilizing its Cell-in-a-Box® live-cell encapsulation technology., has begun the pilot phase of its two-phase pig study. The pig study is the final of several FDA requirements that PharmaCyte (NASDAQ: PMCB), has met in order to lift the clinical hold on Phase 2b clinical trial for locally advanced, inoperable pancreatic cancer (LAPC).
The initial phase, which began today, consists of a brief pilot study on two pigs. This pilot study aims to evaluate the microcatheter-based delivery of CypCaps into the pancreatic arterial system. Using imaging and histology, the dose volume, number of CypCaps, and treatment location will be evaluated. In addition, the CypCaps utilized in the study will contain radiopaque microspheres that will be evaluated to track their movement. The data acquired from the pilot study will enable us to finalize the methodology for the full-scale investigation involving 90 pigs. Then, we will present the protocol to the FDA during our scheduled Type A meeting, which will allow us to interact with the FDA and receive direction regarding this and several other unresolved clinical hold problems. Subject to any protocol modifications suggested by the FDA, we are prepared to proceed with the full-scale study. We believe that this strategy offers the greatest potential for long-term success.
The PharmaCyte Biotech Story
PharmaCyte Biotech, Inc. (NASDAQ:PMCB), is a biotechnology company developing cellular therapies for cancer, diabetes, and malignant ascites using the “Cell-in-a-Box®” live-cell encapsulation technology. Based on this technology, therapies for multiple types of cancer, diabetes, and malignant ascites are being developed. PharmaCyte’s (NASDAQ:PMCB) cancer treatment involves encapsulating genetically engineered human cells that convert an inactive chemotherapeutic drug into its “cancer-killing” active or “active” form. For pancreatic cancer, the encapsulated cells are implanted in the patient’s blood supply as close as feasible to the tumor site. A chemotherapy drug that is normally activated in the liver (ifosfamide) is administered intravenously at one-third the normal dose following implantation.
This press release may possibly contain forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, which reflect the current beliefs and expectations of PharmaCyte’s management and Board of Directors. All statements in this press release that might not be descriptions of historical facts are forward-looking statements that depend on risks and uncertainties that could cause actual results, performance, and achievements to differ materially from those discussed.
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