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 reported that the production of the cells necessary to prepare the Master Cell Bank (MCB) has started. This important work is being carried out by Eurofins, a leading Contract Manufacturing Organization, PharmaCyte selected for this task. Successful development of the MCB is a critical step in PharmaCyte’s preparation for its pancreatic cancer clinical trial.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, “The commencement of the Master Cell Bank (MCB) by Eurofins means that many of the problems discussed during the shareholder call on November 1st have been overcome. When the MCB has been fully populated, the cells will undergo a variety of tests to ensure that they are correct in all respects and then placed in frozen storage for encapsulation and further testing by Austrianova.”
In consultation with principals at Austrianova, PharmaCyte has decided that, once the MCB is fully populated and successfully tested, cells from the MCB will be shipped to Austrianova and used for encapsulation. These encapsulated cells will then be used, along with low-doses of the cancer prodrug ifosfamide, in PharmaCyte’s pancreatic cancer clinical trial.
Waggoner added, “PharmaCyte has decided to proceed with only the MCB for the upcoming clinical trial and, as previously discussed, a Working Cell Bank (WCB) is not required. This will save both a significant amount of time and cost for PharmaCyte in the overall development process of the production of the encapsulated cells.
“The decision to forego a WCB was made because we believe that the MCB will contain more than enough cells for the clinical trial. The goal is to validate PharmaCyte’s unique technology at the earliest opportunity.”
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.
PharmaCyte Biotech, Inc.
Dr. Gerald W. Crabtree
Investor Relations Department