Silver Spring, MD — October 13, 2014 — Nuvilex, Inc. (OTCQB: 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® treatment for pancreatic cancer. If granted, Orphan Drug Designation in the United States will provide Nuvilex special development and commercial assistance from the FDA, including a 7 year period of marketing exclusivity. This latest submission of Nuvilex’s pancreatic cancer treatment for the Orphan Drug Designation follows the application Nuvilex recently made to the European Medicines Agency (EMA) in September, 2014.
Nuvilex’s pancreatic cancer treatment combines the Cell-in-a-Box® 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® 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 Nuvilex’s pancreatic cancer treatment, and we look forward to hearing back from the FDA regarding our application,” commented Kenneth L. Waggoner, Nuvilex’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, Nuvilex’s pancreatic cancer treatment qualifies for consideration by the FDA for Orphan Drug Designation.
Nuvilex (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®. 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. Nuvilex’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, Nuvilex 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® technology. Nuvilex is also developing cancer treatments based upon chemical constituents of Cannabis, known as cannabinoids. To do so, Nuvilex is examining ways to exploit the benefits of the Cell-in-a-Box® technology in optimizing the anticancer effectiveness of cannabinoids, while minimizing or outright eliminating the debilitating side effects usually associated with cancer treatments. This provides Nuvilex 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.