LAGUNA HILLS, Calif.--(BUSINESS WIRE)--PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage 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 that its Chief Executive Officer, Kenneth L. Waggoner, and PharmaCyte’s consultant cellular biologist, David Judd, will be on site at Austrianova’s GMP manufacturing facility in Bangkok, Thailand, as the production of its clinical trial material for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) is underway.
Mr. Waggoner and Mr. Judd will observe the culturing of the genetically altered HEK-293 cells both before and after they are encapsulated. Mr. Judd has a broad array of experience in development of cell culture media for many primary cells and cell lines and is particularly knowledgeable in the growth of HEK-293 cells. He has developed manufacturing processes, cell assays, biochemical analysis, cell culture processes and downstream recovery strategies. Although Mr. Judd has already offered advice to both PharmaCyte and Austrianova via telephonic communications, his actual on-site presence should prove to be invaluable. Mr. Judd will lend assistance in helping correct any unforeseen problems in the production process as the latest two staggered manufacturing “runs” are carried out and completed.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “After the changes to the manufacturing process allowed us to get back on track and proceed with GMP production of the “CypCaps,” our clinical trial product for the company’s planned clinical trial in LAPC, I felt it was necessary to be on-site with David, our consulting expert in the culture of HEK-293 cells, to oversee the process and ensure we are staying on the path and clinical trial development timeline that we’ve developed to submit our Investigational New Drug application (IND). His presence will be particularly important since this time two manufacturing runs will be performed in a staggered fashion rather than consecutively as has been done in the past.”
While in Thailand, Mr. Waggoner, Mr. Judd, Prof. Dr. Walter H. Günzburg and Dr. Brian Salmons of Austrianova and possibly others will be interviewed on the progress of the production, the testing of the clinical trial product, factors involved in the manufacturing process that will be included in the submission of the IND and various other topics related to the company’s planned clinical trial in LAPC.
While on-site at the GMP facility in Thailand, the company expects to post pictures, videos and interviews on its social media platforms. Shareholders and others who are interested in PharmaCyte’s content, should follow the company’s social media platforms:
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage 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 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. PharmaCyte is exploring the use of genetically modified liver cells, stem cells and/or 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 will function as a “bio-artificial pancreas” for purposes of insulin production.
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement because of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements due to the impact of numerous risk factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. Information may also be obtained by contacting PharmaCyte’s Investor Relations Department.