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 Eurofins Lancaster Laboratories, a leading Contract Manufacturing Organization that PharmaCyte selected to prepare its Master Cell Bank (MCB), has successfully completed its independent growth evaluation of the cells that PharmaCyte will use in its Cell-in-a-Box®-based pancreatic cancer therapy. This is a significant step in preparing for PharmaCyte’s pancreatic cancer clinical trial.
Commenting on the cell testing, PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “The satisfactory completion of this important work by Eurofins is good news. Now the door is open for Eurofins to grow the cells that will be necessary to populate our Master Cell Bank. We have authorized Eurofins to begin production of the MCB. Once that is completed, the MCB will be shipped to Austrianova for encapsulation into what will ultimately become our clinical trial product.”
This vital step in the overall product development process has been achieved using the optimal cell culture medium, which has only recently become available. The growth evaluation of the cells is a necessary pre-step to produce the MCB, which is required to comply with FDA guidelines. During the process, Eurofins independently confirmed Austrianova’s selection of cell culture medium for optimal cell growth as well as the growth kinetics of the cells themselves. The cells from the MCB will go on to become the “engine” of the Cell-in-a-Box® encapsulated cell product for the treatment of pancreatic cancer.
“We are pleased to be working with Eurofins, who has been both professional and interactive, during this process leading up to what will be the creation of PharmaCyte’s Master Cell Bank of the cells that make up the Cell-in-a-Box® encapsulated cell product for the treatment of pancreatic cancer. This step certainly clears the way to produce the MCB,” stated Prof. Walter H. Günzburg, Chairman of the Board and Chief Development Officer of Austrianova and PharmaCyte’s Chief Scientific Officer.
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.
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.
Investor Relations:
PharmaCyte Biotech, Inc.
Dr. Gerald W. Crabtree
Investor Relations Department
917.595.2856
[email protected]
