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 steps necessary for the testing of cells from its Master Cell Bank (MCB) have been completed by Eurofins Lancaster Laboratories and that testing began last month. The preparatory work involved the removal of a sample of cells from the MCB and then growing them in a certain way for the complete battery of tests that must be completed.
The cells will undergo many tests. The cells must “pass” these tests to comply with regulations for the use of live cells in humans in the way that PharmaCyte plans to employ them. Eurofins has already commenced the testing and will conduct all but two of the tests. Two of the tests will be outsourced to a subcontractor of Eurofins.
The tests being conducted vary in terms of time to completion. However, when the sterility and mycoplasma tests by Eurofins are finished and the cells “pass” these tests, vials of cells from the MCB will be shipped to Austrianova to manufacture PharmaCyte’s clinical trial material. Regulations require that before the cells, which are placed inside a syringe, can be shipped to PharmaCyte to use in a clinical trial, they must undergo further testing both for sterility and mycoplasma, as well as for a number of functional tests. The results from these tests and the data generated from the encapsulation process must be included in the Investigational New Drug Application (IND) PharmaCyte plans to file with the U.S. FDA.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, “We are pleased to see the completion of the preparatory work so soon after the completion of the MCB. We are excited that testing of cells from the MCB is underway. Given the work done to date, our selection of Eurofins to perform our “cell work” has proven beneficial to the work PharmaCyte has ahead of it. We are eagerly awaiting the day we’re able to ship vials of our MCB to Austrianova for encapsulation.”
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. 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.