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 Master Cell Bank (MCB) of cells that will be used in its upcoming trial in patients with locally advanced non-metastatic and inoperable pancreatic cancer has been fully populated. This work was done for PharmaCyte by Eurofins Lancaster Laboratories in Lancaster, Pennsylvania. Eurofins is one of the largest commercial contract laboratories in the world providing comprehensive laboratory services in the pharmaceutical, biopharmaceutical and environmental sciences sectors.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, “We are very pleased by the quality and timeliness of the work done by Eurofins on our behalf. The satisfactory production of the MCB has completed a very important step as we continue to make progress with preparations for our planned pancreatic cancer clinical trial. The availability of our preferred cell culture medium made a significant difference in our ability to achieve this milestone.”
As previously announced, rather than now expanding the MCB into a Working Cell Bank (WCB) which would then supply vials of cells for encapsulation by Austrianova using the Cell-in-a-Box® technology as part of PharmaCyte’s pancreatic cancer therapy, the company has decided to use vials of cells from the MCB for this purpose. This decision was made because the MCB contains far more vials of cells than needed for use in the planned clinical trial and will accelerate PharmaCyte’s clinical development timeline.
Now that population of the MCB has been completed, cells from the MCB must undergo a variety of tests to satisfy regulatory requirements. The first set of tests will be conducted by Eurofins. Once satisfactory test results are received, the vials of cells will be shipped to Austrianova for encapsulation and further testing. Using vials from the MCB will save a significant amount of time required by Austrianova to generate the data required by the FDA to be included in PharmaCyte’s Investigational New Drug (IND) Application.
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]
