LAGUNA HILLS, CA, September 8, 2020 (BUSINESS WIRE) — PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical-stage biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that it has successfully completed the second Container Closure Integrity (CCI) test that is required by the U.S. Food and Drug Administration (FDA) for its CypCaps™ product. This is the second FDA-required test on the product that will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed test, “We are pleased to announce our Cell-in-a-Box® encapsulated cell product CypCaps™ has passed the second CCI test. This test is a component of the 24-month stability study of our CypCaps™. As we explained previously, the CCI test is part of the ongoing study to determine the shelf life of the CypCaps™ final product that the FDA requires for all medical products. The data from the second CCI test will be submitted to the FDA to be included in our recently submitted Investigational New Drug Application (IND).”
Regulatory agencies around the world, including the FDA, require a shelf-life determination for all medical products. Living products, like cell therapies such as CypCaps™, are particularly sensitive and more prone to inactivation over time. Accordingly, it is especially important to determine the shelf-life for PharmaCyte’s clinical trial product.
The FDA specifically required a CCI test be run on PharmaCyte’s clinical trial product and that the data from the CCI test be included in an ongoing basis in PharmaCyte’s IND.
More can be read about the specifics of the CCI test in PharmaCyte’s June 15, 2020, press release: https://pharmacyte.com/pharmacyte-biotech-successfully-accelerates-development-of-container-closure-integrity-test-for-pancreatic-cancer-clinical-trial-product/
To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: https://www.PharmaCyte.com/Cancer
About PharmaCyte Biotech
PharmaCyte Biotech, Inc. (PharmaCyte) is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed.
PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in little to no treatment related side effects.
PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human liver cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is also considering the use of genetically modified stem cells to treat diabetes. The encapsulation whatever cell line shows the most promise will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, we anticipate that they will function as a “bio-artificial pancreas” for purposes of insulin production.
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of the management of PharmaCyte, including the timing and commencement of our planned Phase 2b clinical trial in LAPC, which is subject to IND approval. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results include our ability to raise the necessary capital to fund our operations and to find partners to supplement our capabilities and resources, our ability to submit and get approved our pending IND, as well as such other factors that are included in the periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. These forward- looking statements are made only as of the date hereof, and we undertake no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. Information may also be obtained by contacting PharmaCyte’s Investor Relations Department.
Dr. Gerald W. Crabtree
PharmaCyte Biotech, Inc.
Investor Relations Department