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 his team are now in Bangkok, Thailand. They have been attending meetings on site at Austrianova’s GMP manufacturing facility. Production of PharmaCyte’s clinical trial material for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) is already underway.
On Tuesday, June 11, Mr. Waggoner and PharmaCyte’s consultant cellular biologist, David A. Judd, will observe and assist the team from Austrianova, if needed, as they continue their work to produce the necessary clinical trial material for PharmaCyte’s planned clinical trial for LAPC.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the necessity to be on the ground at the GMP production facility, “We are at a very crucial point on our path to a clinical trial. The production of our clinical trial material is vital to our success in the clinic, and it is vital to advancing our clinical development timeline. We need the testing of the finished cancer product to get underway. The data from those tests should enable us to complete our Investigational New Drug application (IND). After the changes Austrianova made to the manufacturing process, about which we have already reported, we are back on track. We’ll be here in Thailand overseeing the production runs that will produce the clinical trial material PharmaCyte needs to continue its journey to the clinic.”
Also, a film crew will be on hand to document the company’s manufacturing process for the production of a video that will tell PharmaCyte’s pancreatic cancer therapy story in its entirety.
As a reminder, 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 for over 35 years, 30 of which have been with a major biotechnology company in the United States.
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.