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Nuvilex Secures Worldwide License for Insulin-Producing Cells for Use in Developing Diabetes Treatment

SILVER SPRING, Md., Oct. 16, 2014 — 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. Gunzburg, 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.”