LAGUNA HILLS, CA, January 15, 2019 (BUSINESS WIRE) — PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced PharmaCyte’s partner, Austrianova, has successfully encapsulated the live cells used in PharmaCyte’s therapy for its planned clinical trial in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC). The cells are now growing and dividing inside the Cell-in-a-Box® capsules.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “We are now in the process of monitoring the growth and division of the live cells as they spend more time in a ‘nutrient bath.’ This will allow the cells to continue to grow and divide and then completely fill the capsules. Once the capsules are completely full of live cells, they will be placed into syringes and frozen. Austrianova will then commence testing the capsules in the frozen syringes to finalize PharmaCyte’s clinical trial material.”
Since its pre-production “engineering runs” in late 2018, Austrianova has further enhanced the manufacturing process and equipment. Once the testing of the syringes is successfully completed, the data and reports generated from this process will allow the completion of the Investigational New Drug application (IND) that must be submitted to the U.S. Food and Drug Administration (FDA) to apply for approval to begin a clinical trial in LAPC.
About PharmaCyte Biotech
PharmaCyte Biotech 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 no treatment related side effects.
PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The cell lines being studied are human liver cells, stem cells and beta islet cells. The encapsulation will be done using the Cell-in-
a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they are designed to 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 Biotech, including statements regarding the timing and commencement of our first Phase 2b clinical trial. 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 are included in the periodic reports on Form 10-K and Form 10-Q that we file with the 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