LAGUNA HILLS, Calif., Oct. 24, 2016 (GLOBE NEWSWIRE) — PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that Manuel Hidalgo, MD, PhD has agreed to serve as the Principal Investigator (PI) for PharmaCyte’s clinical trial in patients with locally advanced, inoperable pancreatic cancer (LAPC). Dr. Hidalgo is an internationally respected oncologist and a recognized authority in the treatment of pancreatic cancer. Currently, he serves as Clinical Director of the Leon V. & Marilyn L. Rosenberg Clinical Cancer Center and Chief of the Division of Hematology-Oncology at the prestigious Beth Israel Deaconess Medical Center in Boston and is a member of PharmaCyte’s Medical and Scientific Advisory Board.
Commenting on his selection, Dr. Hidalgo said, “I am pleased to have been selected to be the PI of this important clinical trial, having been a part of its overall design. I have been involved in numerous successful clinical trials and will be drawing on that experience in this one. I believe that the Cell-in-Box® plus low dose ifosfamide combination chemotherapy may well prove to be of great value for the development of new therapies for pancreas and other solid tumor cancers. This novel technology has exceedingly broad application. I am looking forward to working with other clinical oncologists in the U.S. and in Europe to insure that PharmaCyte’s therapy meets the critical unmet medical need the study is designed to address.”
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, also commented, “As we close in on an engagement date with the FDA, we are extremely pleased and fortunate that Dr. Hidalgo has agreed to assume the important position of PI for our clinical trial in patients with LAPC. The available treatments of this disease are only marginally effective. Dr. Hidalgo is well known around the world as an expert in successfully developing therapies for pancreatic cancer, the third deadliest of all forms of cancer. Dr. Hidalgo’s acceptance of the role of PI for our clinical trial lends credence to our belief that PharmaCyte’s therapy will be successful in treating patients with LAPC.”
In his role as PI, or “general supervisor” for how the trial is conducted, Dr. Hidalgo will be responsible for ensuring that all of the clinical trial study sites conduct their studies in accordance with the clinical trial protocol and that all associated procedures and regulations are followed by those study sites. As PI, Dr. Hidalgo will also play a major role in developing the final clinical trial report that will be presented to the FDA, which summarizes and analyzes the trial results from all of the study sites.
PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane® plus gemcitabine. The study will be open-label and multi-site in nature, with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of the prodrug to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they become operable.
About PharmaCyte Biotech
PharmaCyte Biotech a clinical stage biotechnology company developing 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. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. 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 comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate 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 an “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “plan” and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte’s ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations: PharmaCyte Biotech, Inc. Investor Relations Department Telephone: 917.595.2856 Email: [email protected]
