Trial to Also Include Study Sites in Europe and Australia
SILVER SPRING, Md., Oct. 19, 2015 (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®, announced today that its upcoming clinical trial designed to determine whether its pancreatic cancer treatment (Cell-in-a-Box® capsules + low-doses ifosfamide chemotherapy) can satisfy a critical unmet medical need for patients with pancreatic cancer will be conducted in the United States with additional study sites in Europe and Australia.
The decision to conduct the clinical trial in the United States was made because of the need to accelerate the enrollment of patients into the trial and to conduct it in a way that best offers PharmaCyte Biotech the opportunity to get its pancreatic cancer treatment to patients as quickly as possible. If the trial is successful, this could accelerate the review process by drug regulatory authorities for marketing approval of the treatment. In addition, the combination of Abraxane® + gemcitabine is considered to be the “gold standard” for the treatment of patients with advanced pancreatic cancer in the United States, in numerous countries throughout Europe and in Australia. In each of these countries, once patients fail to respond further to the Abraxane® + gemcitabine combination, subsequent therapies are only marginally effective. The goal of PharmaCyte Biotech’s treatment is to fill this void as part of a new “consolidation therapy” for pancreatic cancer patients.
Two of the world’s leading Clinical Research Organizations (CRO), Translational Drug Development (TD2), the premier CRO in the United States specializing in oncology on the forefront of cancer research, and Clinical Network Services (CNS), recently voted Australia’s “best” CRO, will work together conducting the clinical trial. TD2 has assumed the lead role and will be responsible for clinical development plans, program analysis, medical writing, clinical management and database development. TD2 will conduct the clinical trial in the United States. CNS will conduct the clinical trial in Europe and Australia, in alliance with TD2.
PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, stated, “We believe that, by conducting our upcoming clinical trial in the United States, Europe and Australia, enrolling patients in the clinical trial will be much faster than previously planned and the overall timeline for the trial will be optimized. We selected TD2 to be the lead CRO because TD2 is setting the standard for new oncology drug approvals in the United States. TD2 is unique in its comprehensive understanding of oncology clinical development. TD2’s world renowned experts in science and medicine have time and again demonstrated their deep commitment to scientific discovery and innovation.”
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®”. This unique and patented technology will be used as a platform upon which treatments for several types of cancer and diabetes are being developed.
PharmaCyte Biotech’s treatment for cancer involves encapsulating genetically modified live cells capable of converting an inactive chemotherapy drug (ifosfamide) into its active or “cancer-killing” form. These encapsulated live cells are placed as close to a cancerous tumor as possible. Once implanted in a patient, ifosfamide is then given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been placed. When ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells, activation of the drug takes place at the source of the cancer without any side effects from the chemotherapy. This “targeted chemotherapy” has proven remarkably effective and safe to use in past clinical trials.
In addition to developing a novel treatment for cancer, PharmaCyte Biotech is developing a treatment for Type 1 diabetes and Type 2 insulin-dependent diabetes. PharmaCyte Biotech plans to encapsulate a human cell line that has been genetically engineered to produce, store and secrete insulin at levels in proportion to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology.
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 Biotech or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte Biotech, 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 Biotech’s intellectual property and PharmaCyte Biotech’s continued ability to raise capital. PharmaCyte Biotech 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: Info@PharmaCyte.com