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 it has received Certificates of Analysis and final reports of all tests that were performed by its contractor Eurofins on cells from PharmaCyte’s Master Cell Bank (MCB). The cells that underwent testing will be encapsulated and then used in PharmaCyte’s planned clinical trial in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, “We are very pleased that the final reports of the rigorous testing of our MCB cells have been received from Eurofins and, most importantly, that Certificates of Analysis for each of the 29 tests have been issued by Eurofins. The reports that each of these tests generated will play a significant role in our IND submission to the U.S. FDA, principally because the regulatory agency required PharmaCyte to conduct all the tests that were done on our cells. It also allows Austrianova to begin the process of encapsulating the cells we shipped to Austrianova from our MCB."
The reports by Eurofins on the 29 different tests done on the cells were comprehensive and very detailed. Not only were actual test results and Certificates of Analysis contained in the 67-page report, but comments by Eurofins’ Quality Control/Quality Assurance Departments were also included as part of the extensive reports.
Also, we’d like to remind shareholders of the recorded interview with the company’s Chief Executive Officer, Kenneth L. Waggoner, and its Chief Scientific Officer, Prof. Walter H. Günzburg, that was published on our website yesterday. Shareholders can listen to the interview with the CEO and CSO at: www.PharmaCyte.com/News/Media
The interview covered such topics as the current status of the Investigational New Drug Application (IND), what remains outstanding in order to complete the IND, the live-cell encapsulation process at Austrianova in Thailand, the trial design for the clinical trial in patients with LAPC, the selection process of the Contract Research Organization (CRO) for the clinical trial and a number of other topics.
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.
