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Nuvilex (NVLX) Submits Application For Orphan Drug Designation To The European Medicines Agency For Its Cell-In-A-Box® Treatment For Pancreatic Cancer


9/2/2014 10:41:03 AM

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SILVER SPRING, Md., Sept. 2, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage, international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that it has submitted an application to the European Medicines Agency (EMA) for an Orphan Drug Designation for its Cell-in-a-Box® treatment for pancreatic cancer. Nuvilex's pancreatic cancer treatment consists of the combination of Cell-in-a-Box® with low doses of the anticancer drug ifosfamide. The Cell-in-a-Box® portion of the treatment consists of live cells capable of converting ifosfamide into its cancer-killing form that have been enclosed in protective pin-head sized spherical capsules that are composed of bio-inert cellulose.

This first submission of Nuvilex's pancreatic cancer treatment is being made in Europe because, in the mid-2000s, an application for the Orphan Drug Designation for the encapsulated live cell (Cell-in-a-Box®) component of the pancreatic cancer treatment was approved in principle in Europe by the precursor to the EMA - the EMEA. The sponsor of this application is Nuvilex's newest subsidiary, Nuvilex Europe Limited, which was recently formed to develop and commercialize treatments for cancer and diabetes throughout the European market.

Kenneth L. Waggoner, Nuvilex's CEO and President, commented, "The submission of this application for the Orphan Drug Designation represents a major step in the development process for Nuvilex's pancreatic cancer treatment. If the Orphan Drug Designation is granted, Nuvilex could receive special assistance in its treatment's development process, exemptions or reductions in regulatory fees from the EMA and a very significant period of marketing exclusivity of 10 years for its treatment of pancreatic cancer.

"Since the cellulose-based encapsulation of live, ifosfamide-activating cells for their use in treating pancreatic cancer has been previously approved in principle for the Orphan Drug Designation in Europe, we are encouraged that this will be the case once again, particularly given that additional data have been submitted to support the new application and the fact that the Cell-in-a-Box® technology has matured significantly since the previous application. Europe is just the first of several markets in which Nuvilex plans to submit similar applications for the Orphan Drug Designation. The United States and Australia are two such markets."

The Orphan Drug Designation is given to drugs or treatments for "rare," life-threatening diseases. In Europe, a rare disease is defined as one that occurs in less than 5 of every 10,000 people. According to incidence estimates, the prevalence of pancreatic cancer in the European Union is less than 1.5 cases per 10,000 people, a figure significantly below that required for Nuvilex's pancreatic cancer treatment to qualify for the Orphan Drug Designation.

The fact that 82,000 deaths from pancreatic cancer are predicted in the European Union in 2014, that it is incurable in more than 95% of patients and that median survival is much less than one year all testify to the life-threatening nature of the disease. Importantly, as noted above, the Orphan Drug Designation in Europe for a drug or treatment carries with it an extension of 10 years of marketing exclusivity after marketing approval is granted by the EMA.

Mr. Waggoner added, "Special thanks for the preparation of this application must be given to Ms. Natalie Thomas of Clinical Network Services, the Clinical Research Organization contracted by Nuvilex to carry out our Phase 2b trial in pancreatic cancer, to Dr. Prof. Walter H. Günzburg and Dr. Brian Salmons of Austrianova who were co-developers of the Cell-in-a-Box® technology and who jointly contributed to the application and to Dr. Matthias Löhr, the Principal Investigator for the two completed clinical trials, who was also a significant contributor to the application and who will oversee all aspects of the future development of Nuvilex's pancreatic cancer treatment."

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 widely used anticancer prodrug ifosfamide, together with encapsulated live cells, which convert ifosfamide into its active or "cancer-killing" form. Nuvilex is also working towards clinical trials associated with the symptoms of advanced pancreatic cancer and other abdominal cancers.

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.

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

CONTACT: Investor Relations Contacts: Marlin Molinaro Marmel Communications, LLC Phone: 702.434.8692 mmolinarofc@aol.com

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