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Nuvilex Secures Worldwide License for Insulin-Producing Cells From University of Technology, Sydney, for Use in Developing Diabetes Treatment

SILVER SPRING, Md., Oct. 16, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage biotechnology company developing cell and gene therapy solutions for the treatment of diseases, announced today that it has entered into a license with the University of Technology in Sydney, Australia (UTS), that grants Nuvilex the worldwide rights to use human insulin-producing cells, termed "Melligen" cells, developed by Prof. Ann Simpson and her colleagues at UTS for the development of a treatment for insulin-dependent (Type 1 or juvenile-onset) diabetes. Type 1 diabetics are unable to produce the insulin required to transport glucose (blood sugar) from the blood to the inside of cells where it is used as a source of energy. The beta islet cells of the pancreas (Islets of Langerhans) of Type 1 diabetics that normally produce insulin have been destroyed by an autoimmune disease.

Prof. Simpson said of the opportunity to further the Melligen cell line, "I am pleased that after many years of diabetes research at UTS, Nuvilex will now be developing this technology for commercialization to a global market. My team and I are excited by the prospect of working with Nuvilex to eliminate daily injections for insulin-dependent diabetic patients."

Nuvilex's CEO and President, Kenneth L. Waggoner, commented, "The execution of this exclusive worldwide license with UTS for the use of the Melligen cells represents a major milestone in Nuvilex's efforts to develop a treatment for Type 1 diabetes. This is a disease that affects millions of individuals around the world. Some of the complications diabetics suffer from are eye disease, foot and leg problems, kidney disease and cardiovascular disease. These complications can be dangerous and even life-threatening. If we are successful, those inflicted with Type 1 diabetes will be freed from depending on daily insulin injections or the use of insulin pumps as well as the constant need to monitor their blood glucose levels and modify their diets."

Melligen cells were originally derived from a human liver cancer cell line. Use of the Melligen cells is contingent upon whether they form tumors when implanted into animals – in other words, whether they are tumorigenic. Experiments will be carried out at the University of Veterinary Medicine in Vienna, Austria, under the leadership of Prof. Dr. Walter H. Günzburg, a Professor of Virology at that university and the Chief Scientific Officer of Nuvilex and the Chairman and Chief Technology Officer of Nuvilex's partner companies, SG Austria and Austrianova. These experiments are designed to determine whether or not the Melligen cells are tumorigenic. If the Melligen cells prove to be tumorigenic, attempts will be made to genetically modify them so that they are no longer tumorigenic or an alternative non-tumorigenic insulin-producing cell line will be developed.

If the Melligen cells are not tumorigenic, Nuvilex plans to have them encapsulated using the novel and proprietary Cell-in-a-Box® cellulose-based live cell technology as part of its planned treatment for diabetes. It is believed that animal testing of the encapsulated Melligen cells will prove that they are capable of producing insulin "on demand" in diabetic animals. As blood glucose levels rise in animals implanted with Melligen cells, these cells will produce increasing amounts of insulin in response. When blood glucose levels fall, less insulin will be produced by the Melligen cells. Ultimately, encapsulated Melligen cells will be placed into patients with Type 1 diabetes where, hopefully, they will serve as a form of "bio-artificial pancreas." In laboratory studies, Melligen cells have been shown to respond directly to the amount of glucose in their surroundings. They have already been successfully encapsulated using the Cell-in-a-Box® technology.

Mr. Waggoner stated further, "Nuvilex's Cell-in-a-Box®-based treatment, which will serve as a type of bio-artificial pancreas, will differ from those being developed by other companies in a number of ways. First, unlike the efforts of other companies, the cells Nuvilex will be using are not obtained from the pancreas - they are not insulin-producing pancreatic beta islet cells. Significant difficulties have been encountered in keeping such islet cells alive and functioning after they have been implanted inside the body. Second, we believe the cellulose-based Cell-in-a-Box® capsules are more capable of maintaining the lifespan and function of the encapsulated cells inside the body than are the other cell encapsulation materials, such as alginate (derived from seaweed), used by others. Third, when present in the body, Cell-in-a-Box® capsules do not cause irritation or inflammation of surrounding tissues. Fourth, these capsules do not break down even after long periods of time (greater than 2 years) after implantation in the body. Finally, the Cell-in-a-Box® capsules do not elicit a response from the body's immune system that would destroy the capsules and the insulin-producing cells inside them. In our opinion, similar statements cannot be made for other diabetes treatments based on live cell encapsulation that are being developed anywhere in the world in an effort to produce a long-lasting bio-artificial pancreas."

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 low doses of the anticancer prodrug ifosfamide and encapsulated live cells that convert ifosfamide into its active or "cancer-killing" form. Nuvilex is also 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. In addition, Nuvilex is 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.

Safe Harbor

This press release may contain forward-looking statements regarding Nuvilex 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 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 its 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: Clare Matschullat Blueprint Life Science Group Telephone: 415.375.3340 Ext. 106 cmtschullt@bplifescience.com

Source:Nuvilex, Inc.