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 the European Commission has updated its website to reflect that PharmaCyte Biotech Europe Limited, a subsidiary of PharmaCyte Biotech, Inc., is the "sponsor" or holder of the Orphan Drug designation in Europe for PharmaCyte's pancreatic cancer treatment.
The European Commission's website is now available to verify that the Orphan Drug designation has been obtained by PharmaCyte.
PharmaCyte has been assured that the European Medicines Agency (EMA) is in the process of updating its records to reflect that PharmaCyte has obtained the Orphan Drug designation. Receiving the Orphan Drug designation in Europe 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 would be cost justified to treat the life threatening disease, and that the drug has been shown to provide a significant benefit to patients being treated by the drug.
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 that convert 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.
