Nuvilex's Preparations for Planned Late-Phase Clinical Trials Timely in Light of Increasing Incidence of Pancreatic Cancer

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SILVER SPRING, Md., Dec. 12, 2013 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (OTCQB:NVLX), an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, commented today that ongoing preparations for its planned late-phase clinical trials appear to be timely as recent reports in the scientific literature point to an ever-increasing incidence of pancreatic cancer.

In an article by J. Ma, R. Seigel, and A. Jemal of the American Cancer Society published in November, 2013 in the Journal of the National Cancer Institute (JNCI), the authors revealed that in the U.S., from 1995 to 2009, death rates from pancreatic cancer in white males rose by 0.4% per year and 0.5% in white females. During the same period, death rates from the disease dropped by 0.9% in black males and by 0.5% in black females. Despite these trends, the proportion of black people who died from the disease remained consistently higher than for white people.

In the same issue of JNCI, in a commentary on the article, Drs. D. Cardin and J. Berlin of the Vanderbilt Ingram Cancer Center, opined that, despite the fact that the rising incidence of death from pancreatic cancer seems to be limited to whites, the study by Ma, et al. "highlights a looming crisis of rising pancreatic death rates in the United States." Furthermore they state that better health, earlier diagnosis and better chemotherapeutic treatment regimens will be needed to stem the rising tide of this deadly disease because the currently available treatment regimens of FOLFIRINOX, a four-drug combination, and Celgene's treatment of gemcitabine plus Abraxane® are associated with a median survival of less than one year. In their words, there is "a need to abandon the mindless propagation of the 'gemcitabine + your drug here' design of chemotherapeutic regimens used for over a decade."

The pancreatic cancer treatment under development by Nuvilex represents a marked departure from the "gemcitabine +" or FOLFIRINOX treatments in that it combines lower than usual doses of a single well-known anticancer prodrug, ifosfamide, with the proprietary cellulose-based live-cell encapsulation technology, called Cell-in-a-Box, that utilizes cells capable of converting ifosfamide into its "cancer-killing" form. In early-mid phase clinical trials, when trial data were compared with available data for gemcitabine alone, the gemcitabine + Abraxane combination of FOLFIRINOX, Nuvilex's treatment appeared to be superior in terms of median survival and/or one-year survival rates. Furthermore, the side effects associated with Nuvilex's treatment were far less severe than those associated with any of the other three treatment regimens.

Dr. Robert F. Ryan, Nuvilex's Chief Scientific Officer stated, "Despite the efforts of many entities to develop new treatments for pancreatic cancer since gemcitabine (Gemzar®) was approved by the FDA in 1996, several of which included gemcitabine, success has been limited. Given the apparent increasing incidence of pancreatic cancer, new treatments for the disease are urgently needed, particularly those that do not depend on gemcitabine for part of their anti-cancer activity. We hope that the efforts currently underway to develop our ifosfamide / live-cell encapsulation combination will ultimately result in a more successful and less toxic avenue of treatment for those suffering from this dreadful disease than the treatments currently available."

About Nuvilex

Nuvilex is a biotechnology company with the rights to a novel cellulose-based, live-cell encapsulation technology, called Cell-in-a-Box, that will be used as a platform upon which treatments for several types of cancer, including advanced, inoperable pancreatic cancer and diabetes are being built. The Company's treatment for pancreatic cancer involves the use of the widely used anticancer prodrug, ifosfamide, together with encapsulated live cells that convert ifosfamide into its active or "cancer-killing" form. Nuvilex's subsidiary, Medical Marijuana Sciences, Inc., is dedicated to the development of cancer treatments based upon the well-known chemical constituents of marijuana. Nuvilex is exploring ways in which the Cell-in-a-Box technology may play a role in these efforts.

Safe Harbor

This press release may contain forward-looking statements regarding Nuvilex and its future events and results that are subject to the safe harbors created under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, included in this press release regarding Nuvilex's financial position, business strategy, plans and objectives of management for future operations and business conditions are forward-looking statements.

Forward-looking statements involve inherent risks and uncertainties. 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, but are not limited to, the following: (i) general economic or business conditions; (ii) changes in legislation or regulatory requirements; (iii) conditions of the securities markets; (iv) Nuvilex's ability to raise capital; (v) changes in accounting principles, policies or guidelines; (vi) financial or political instability; and (vii) other economic, competitive, governmental, regulatory and technical factors affecting the plans, operations, products and services of Nuvilex.

Nuvilex has based these forward-looking statements on its current expectations and assumptions about future events. While management considers these expectations and assumptions to be reasonable, they are inherently subject to significant business, economic, competitive, regulatory and other risks, contingencies and uncertainties, most of which are difficult to predict and many of which are beyond the control of Nuvilex. Nuvilex does not assume any obligations to update any of these forward-looking statements.

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

CONTACT: Investor Relations Contact: Marlin Molinaro Marmel Communications, LLC Ph: (702) 434-8692

Source:Nuvilex, Inc.