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 cells it will encapsulate and then use in its planned clinical trial in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) have successfully passed all 29 tests required by the U.S. Food and Drug Administration (FDA). Most of the tests were conducted by PharmaCyte’s contractor, Eurofins Lancaster Laboratories, Inc. (Eurofins). The rest of the tests were conducted by third party laboratories subcontracted by Eurofins.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “We are pleased that the cells being used in our LAPC trial have now successfully passed all of the rigorous and extensive testing done on them by Eurofins and its subcontractors. The nature of the various tests was quite varied and some of the tests were more complex than others, so we’re excited that the cells, which are at the heart of our pancreatic cancer therapy, could endure such a wide range of testing and pass each and every one. Now that testing is complete and all results are positive, we have been advised by Eurofins that we will have a final Certificate of Analysis next week. With this document in hand, the cell encapsulation process can begin."
Before any tests could be started, cells from the Master Cell Bank had to be thawed from frozen storage and then cultured to obtain enough cells for all of the planned tests. This was completed on January 24, 2018. In all, the cells underwent 29 different tests. Because of processes involved at Eurofins pertaining to the tests, not all tests could begin at the same time.
Once each test was completed, the test results had to be analysed and a report written by Eurofins. Then the conduct and results of each test had to examined and approved by Eurofins’ Quality Assurance/Quality Control department. Now that all the tests have been successfully completed, Eurofins is preparing the necessary Certificate of Analysis to be sent to Austrianova in Thailand where encapsulation will be performed using PharmaCyte’s signature live-cell encapsulation technology. Having the Certificate of Analysis is a cGMP requirement before encapsulation can begin.
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.
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.