$NVLX Gets FDA Orphan Drug Designation

FDA Grants Orphan Drug Designation to Nuvilex for Pancreatic Cancer Treatment

SILVER SPRING, Md., Dec. 22, 2014 (GLOBE NEWSWIRE) — Nuvilex, Inc. (NVLX), a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Nuvilex orphan drug designation for its pancreatic cancer treatment. Nuvilex’s pancreatic cancer treatment combines Nuvilex’s patented and proprietary cellulose-based encapsulation technology, known as Cell-in-a-Box^(R), with the cancer prodrug ifosfamide and encapsulated live cells that convert the prodrug into its cancer-killing form. These capsules are placed as close to the cancerous tumor as possible to enable the delivery of the highest levels of the cancer-killing drug at the source of the cancer. This “targeted chemotherapy” has proven remarkably effective in past clinical trials.

“Receiving orphan drug designation by the FDA represents a significant milestone in the development of our pancreatic cancer treatment. This achievement is a very important one, both for Nuvilex and our partner Austrianova. It not only facilitates the future development of Nuvilex’s pancreatic cancer treatment, but also serves to validate the Cell-in-a-Box^(R) technology,” stated Kenneth L. Waggoner, Chief Executive Officer of Nuvilex.

Nuvilex is currently preparing for a Phase 2b clinical trial in advanced pancreatic cancer (the orphan indication) in Australia to gain regulatory approval from agencies like the FDA for Nuvilex’s targeted chemotherapy of pancreatic cancer. Nuvilex’s clinical trial is planned to commence in 2015.

To access the FDA’s official listing of Nuvilex receiving the Orphan Drug Designation, use this link: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/oopd_results_2.cfm?index_number=457014.

Orphan drug designation in the U.S. is given to drugs or treatments for “rare,” life-threatening diseases. In the U.S., a rare disease is defined as one that is diagnosed in less than 200,000 people in the U.S. In addition, in the U.S. pancreatic cancer can be classified as a life-threatening disease because, even with the best available chemotherapy, patients with advanced pancreatic cancer are destined to live less than one year on average and the 5-year survival rate is less than seven percent.

Receiving orphan drug designation for Nuvilex’s pancreatic cancer treatment carries with it up to 7 years of marketing exclusivity in the U.S. In addition, special assistance from the FDA in the development of Nuvilex’s treatment for pancreatic cancer and exemptions or reductions in regulatory fees and taxes can accompany the designation.

About Nuvilex

Nuvilex 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. Nuvilex’s treatment for pancreatic cancer involves the well-known anticancer prodrug ifosfamide, together with encapsulated live cells, which convert ifosfamide into its active or “cancer-killing” form. In addition, Nuvilex is working towards improving the quality of life for patients with advanced pancreatic cancer and on treatments for other types of solid cancerous tumors. Nuvilex is also developing treatments for cancer based upon chemical constituents of marijuana known as cannabinoids. Nuvilex is examining ways to exploit the benefits of 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 Nuvilex the rare 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 Nuvilex 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 Nuvilex or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of Nuvilex, could cause actual results to differ materially from those set forth in the forward-looking statements. They include Nuvilex’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 Nuvilex’s intellectual property and Nuvilex’s continued ability to raise capital. Nuvilex does not assume any obligation to update any of these forward-looking statements.

More information about Nuvilex can be found at www.nuvilex.com. It can also be obtained by contacting Investor Relations.

Investor Relations Contacts:
Jamien Jones
Blueprint Life Science Group
Telephone: 415.375.3340 Ext. 103
jjones@bplifescience.com