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 the vials of cells from PharmaCyte’s Master Cell Bank (MCB) that were shipped by Eurofins Lancaster Laboratories (Eurofins) to Austrianova’s encapsulation facility in Thailand have arrived safely. The cells from the MCB are now in quarantine before they can be unfrozen, grown and encapsulated. This will be followed by another round of testing that will be performed by Austrianova and its partners after encapsulation, in accordance with U.S. Food and Drug Administration (FDA) guidelines.
Austrianova’s Chief Executive Officer, Brian Salmons, said, “We can report that the vials of cells from the PharmaCyte MCB produced by Eurofins have arrived at our production facility in good condition. Once the necessary quarantine procedures are formally completed, the cells will be unfrozen, grown and encapsulated under cGMP conditions. After completion of the manufacturing process, which includes another round of sterility testing as well as numerous quality control tests, the syringes containing the encapsulated cells will be shipped to PharmaCyte for use in its planned clinical trial.”
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, also stated, “We are pleased to announce the safe arrival of the vials from our MCB vials at Austrianova’s manufacturing facility. All of the data generated by Austrianova, together with the testing data from Eurofins and its subcontractors, will be included in our Investigational New Drug Application (IND) for our planned clinical trial involving locally advanced, non-metastatic, inoperable pancreatic cancer.”
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 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 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.
Safe Harbor
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.
