SILVER SPRING, Md., Nov. 7, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that it has submitted, through its subsidiary Nuvilex Australia, an application to the Therapeutic Goods Administration (TGA) in Australia to obtain the Orphan Drug Designation for its pancreatic cancer treatment. This submission follows similar applications to the United States Food and Drug Administration and the European Medicines Agency in the European Union (EU). Like those in the U.S. (7 years) and the EU (10 years), granting of the Orphan Drug Designation carries with it a significant period of marketing exclusivity. In Australia this period is 5 years.
Nuvilex's CEO and President, Kenneth L. Waggoner, commented, "The application for the Orphan Drug Designation in Australia is the third such application made to the drug regulatory authorities in major areas of the world. In order for the Orphan Drug Designation to be granted to a particular drug or treatment, the target disease must be considered life-threatening and 'rare.' Pancreatic cancer, no matter where it occurs in the world, is undoubtedly life-threatening and, in our opinion, its prevalence in Australia classifies it as a rare disease. It is expected that this application to the TGA will be reviewed relatively quickly, and we may have a decision on it before the end of the year."
Nuvilex's pancreatic cancer treatment consists of implanting living cells that have been encapsulated in pin-head sized, cellulose-based, protective "cocoons" through the use of the proprietary Cell-in-a-Box® technology, followed by the administration of low doses of the anticancer prodrug ifosfamide. Ifosfamide is a drug that must be converted into its "cancer-killing" form for it to be effective. The cells that are encapsulated are efficient and effective at carrying out this conversion. By placing these encapsulated ifosfamide-activating cells in proximity to the pancreatic cancer, the anticancer effects of the drug are optimized. In addition, as shown in early-phase clinical trials, because low doses of the anticancer drug are used the side effects from it are greatly reduced in severity and the treatment is well tolerated by the patients undergoing this novel treatment.
Mr. Waggoner continued, "As with the applications for the Orphan Drug Designation in the U.S. and the EU, we are extremely grateful to our colleagues at Clinical Network Services (CNS) for their assistance in the preparation of this Australian submission. In particular, the services of Dr. Natalie Thomas in the preparation and submission of this application were invaluable. CNS, one of Australia's leading Contract Research Organizations, has been contracted by Nuvilex to conduct its Phase 2b pancreatic cancer clinical trial in that country."
About Nuvilex
Nuvilex (OTCQB: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 the well-known anticancer prodrug ifosfamide, together with encapsulated live cells, which convert ifosfamide into its active or "cancer-killing" form. Nuvilex is also working toward improving the quality of life for patients with advanced pancreatic cancer and on treatments for other types of solid cancerous tumors. In addition, Nuvilex is 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® technology in optimizing the anticancer effectiveness of such cannabinoids against cancers, 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.
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, that could cause actual results to differ materially from those set forth in the forward-looking statements 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.
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