SILVER SPRING, Md., Nov. 17, 2015 (GLOBE NEWSWIRE) — PharmaCyte Biotech, Inc. (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, upon the recommendation of the European Medicines Agency (EMA), the European Commission has granted the Orphan Drug designation to PharmaCyte’s subsidiary, PharmaCyte Biotech Europe Limited, for PharmaCyte’s pancreatic cancer treatment. Receiving Orphan Drug designation for PharmaCyte’s pancreatic cancer treatment carries with it 10 years of marketing exclusivity in countries in the European Union. In addition, the EMA provides special assistance in the development of PharmaCyte’s treatment for pancreatic cancer.
The Orphan Drug designation in the European Union is given to drugs for life-threatening diseases with low prevalence, or that make it unlikely an investment in a drug to treat a life-threatening disease would be cost justified, and that demonstrate there is a significant benefit to patients being treated with the drug.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented on the significance of PharmaCyte obtaining the Orphan Drug designation, saying, “Obtaining Orphan Drug designation from the European Commission represents another significant milestone in the development of PharmaCyte’s pancreatic cancer treatment. This achievement is an exceedingly important one when coupled with the FDA’s granting of the same designation last year. It further facilitates the development of PharmaCyte’s pancreatic cancer treatment and once again serves to validate the Cell-in-a-Box® technology as a treatment for one of the most dreaded forms of cancer.”
PharmaCyte’s pancreatic cancer treatment consists of encapsulating genetically modified live cells capable of converting the anticancer prodrug ifosfamide into its cancer-killing form and placing the capsules as close to the cancerous tumor in the pancreas as possible. Then low doses of the inactive chemotherapy drug ifosfamide are given to the patient. When ifosfamide, which is carried by blood to where the capsules have been placed, comes in contact with the live cells, the drug is converted into its cancer killing form at the site of the disease rather than in the liver where conversion normally takes place. This technology enables high concentrations of the chemotherapeutic drug to be delivered directly to the cancer, without any treatment-related side effects like those normally associated with cancer chemotherapy.
PharmaCyte is preparing for a clinical trial designed to determine whether its pancreatic cancer treatment (Cell-in-a-Box® capsules + low-doses of ifosfamide) can satisfy a critical unmet medical need for patients with advanced pancreatic cancer when the gold standard of care, the combination of gemcitabine and Abraxane®, are no longer effective. The trial will be conducted in the United States with additional study sites in Europe and Australia.
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’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 is developing a treatment for Type 1 diabetes and Type 2 insulin-dependent diabetes. PharmaCyte 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 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 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