PharmaCyte Biotech Successfully Completes Manufacturing of Clinical Trial Product
LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Oct 14, 2019--
PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box ®, announced today that its partner, Austrianova Singapore (Austrianova), has completed the first of two staggered and back to back manufacturing runs for the production of PharmaCyte’s clinical trial product.
The first manufacturing run has been completed successfully. A representative sample of frozen syringes filled with the encapsulated cells inside are in the process of being shipped to external testing laboratories for the release testing of the clinical trial product that is required by the U.S. Food and Drug Administration (FDA). The clinical trial product will be used in PharmaCyte’s clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
Also, about two weeks ago, the second of the two manufacturing runs began. The cells from PharmaCyte’s Master Cell Bank (MCB) are reportedly growing well. The plan is to encapsulate them within the next week or two.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “We are exceedingly pleased that Austrianova has successfully manufactured PharmaCyte’s clinical trial product for our clinical trial in LAPC, and we’re equally as encouraged to hear that the second and final manufacturing run is proceeding as expected. During our recent shareholder update call, we committed to keeping our shareholders apprised of material developments related to PharmaCyte’s work in completing its Investigational New Drug application (IND). Today’s announcement is a major milestone towards the completion of that work.
“The efforts undertaken to meet this milestone were monumental and involved everyone associated with the technical aspects of the manufacturing process. We cannot be more thankful to our colleagues at Austrianova and those from PharmaCyte who were involved in the work. I feel strongly that we’re back on track to completing both of the required manufacturing runs that will generate the data needed to complete the IND.”
During PharmaCyte’s shareholder update call on September 20, 2019, it was reported that Austrianova was in the post-encapsulation phase of the first of two staggered and back-to-back manufacturing runs required by cGMP Validation, the company that is taking responsibility for releasing the clinical trial product into the U.S. for use in PharmaCyte’s upcoming clinical trial.
To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: https://www.PharmaCyte.com/Cancer
About PharmaCyte Biotech
PharmaCyte Biotech, Inc. (PharmaCyte) is a 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 little to 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 and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is developing the use of genetically modified liver cells and stem cells, as well as beta islet cells, to treat diabetes. 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 may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of the management of PharmaCyte, including statements regarding the timing and commencement of our first Phase 2b clinical trial. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results are included in the periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof, and we undertake no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise
More information about PharmaCyte can be found at www.PharmaCyte.com. Information may also be obtained by contacting PharmaCyte’s Investor Relations Department.
View source version on businesswire.com:https://www.businesswire.com/news/home/20191014005245/en/
CONTACT: Dr. Gerald W. Crabtree
PharmaCyte Biotech, Inc.
Investor Relations Department
KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA
INDUSTRY KEYWORD: SCIENCE STEM CELLS BIOTECHNOLOGY RESEARCH PHARMACEUTICAL GENERAL HEALTH HEALTH CLINICAL TRIALS
SOURCE: PharmaCyte Biotech, Inc.
Copyright Business Wire 2019.
PUB: 10/14/2019 09:00 AM/DISC: 10/14/2019 09:00 AM