SILVER SPRING, Md., Oct. 13, 2014 (GLOBE NEWSWIRE) — PharmaCyte Biotech, Inc. (NVLX), a clinical-stage biotechnology company developing cell therapy solutions for the treatment of diseases, announced today that it has submitted an application to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for its Cell-in-a-Box(R) treatment for pancreatic cancer. If granted, Orphan Drug Designation in the United States will provide PharmaCyte Biotech special development and commercial assistance from the FDA, including a 7 year period of marketing exclusivity. This latest submission of PharmaCyte Biotech’s pancreatic cancer treatment for the Orphan Drug Designation follows the application PharmaCyte Biotech recently made to the European Medicines Agency (EMA) in September, 2014.
PharmaCyte Biotech’s pancreatic cancer treatment combines the Cell-in-a-Box(R) cellulose-based live cell encapsulation technology with low doses of the anticancer “prodrug” ifosfamide to provide “targeted chemotherapy” to patients suffering from pancreatic cancer. The cells that are enclosed in pin-head-sized capsules during the Cell-in-a-Box(R) encapsulation process convert ifosfamide into its cancer-killing form at or near the site of the tumor to increase the efficiency and effectiveness of a patient’s treatment.
“Submission for Orphan Drug Designation in the U.S. is the next logical step for the development of PharmaCyte Biotech’s pancreatic cancer treatment, and we look forward to hearing back from the FDA regarding our application,” commented Kenneth L. Waggoner, PharmaCyte Biotech’s Chief Executive Officer and President.
Orphan Drug Designation in the United States is given to drugs or treatments for “rare,” life-threatening diseases. In the United States a rare disease is defined as one that is diagnosed in less than 200,000 individuals per year. According to incidence estimates, the prevalence of pancreatic cancer in the United States is less than 50,000 cases annually. As in Europe, there is no doubt that pancreatic cancer is a life-threatening disease in the United States. Even with the best available chemotherapy, those with advanced pancreatic cancer are destined to live less than one year on average, and the 5-year survival rate is less than 7%. On these bases alone, PharmaCyte Biotech’s pancreatic cancer treatment qualifies for consideration by the FDA for Orphan Drug Designation.
About PharmaCyte Biotech
PharmaCyte Biotech (NVLX) 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(R). This unique and patented technology will be used as a platform upon which treatments for several types of cancer, including advanced, inoperable pancreatic cancer, and diabetes are being built. PharmaCyte Biotech’s treatment for pancreatic cancer involves low doses of the anticancer prodrug ifosfamide and encapsulated live cells that convert ifosfamide into its active or “cancer-killing” form. In concert with these efforts, PharmaCyte Biotech is working towards improving the quality of life for patients with advanced pancreatic cancer and on treatments for other types of cancer using the Cell-in-a-Box(R) technology. PharmaCyte Biotech is also developing cancer treatments based upon chemical constituents of Cannabis, known as cannabinoids. To do so, PharmaCyte Biotech is examining ways to exploit the benefits of the Cell-in-a-Box(R) technology in optimizing the anticancer effectiveness of cannabinoids, while minimizing or outright eliminating the debilitating side effects usually associated with cancer treatments. This provides PharmaCyte Biotech a unique opportunity to develop “green” approaches to fighting deadly cancers, such as those of the pancreas, brain and breast, which affect hundreds of thousands of individuals worldwide every year.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future plans 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, that could cause actual results to differ materially from those set forth in the forward-looking statements include PharmaCyte Biotech’s ability to continue as a going concern, delays or unsuccessful results in clinical trials or 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 its forward-looking statements.
Investor Relations Contacts:
Clare Matschullat
Blueprint Life Science Group
Telephone: 917.595.2856 Ext. 106
[email protected]
