SOURCE: Goldman Small Cap Research, Inc.

August 14, 2013 09:03 ET

Nuvilex May Opt for Future Clinical Trials Abroad

BALTIMORE, MD--(Marketwired - Aug 14, 2013) - In a newly released research update, Goldman Small Cap Research, a stock market research firm focused on the small cap and microcap sectors, notes that given the substantial costs to administer and conduct clinical trials exclusively in the U.S., it is likely that Nuvilex, Inc. (OTCQB: NVLX) will elect to turn to overseas locations for future clinical trials. This strategy is routine for most major pharmaceutical firms and it makes perfect sense for an emerging biotechnology firm such as Nuvilex.

According to published reports, in 2008, roughly 6,500 clinical trials were being conducted in foreign countries of drugs intended for American use. In the same year, the inspector general of the Department of Health and Human Services compiled a comprehensive study that demonstrated roughly 80% of the drug applications submitted to the FDA for new drugs contained data generated from clinical trials conducted in foreign lands. 

While the primary reason for a company such as Nuvilex to elect to conduct clinical trials abroad is a reduction in overall operating costs (which could be 20% or more lower than in the U.S.), other considerations can include easier or faster patient enrollment. For example, there are some nations ravaged by certain diseases more than others, or nations whose populace may carry disease-specific genetic markers at a higher rate than others.

Given the success of the predecessor firm that previously owned exclusive rights to the live-cell encapsulation platform to treat pancreatic cancer in Europe, it is possible that Nuvilex management elects to strike gold twice. Or, the Company could elect to conduct trials in Asia and other countries outside the U.S. where cost and enrollment favor the Company. In either event, Nuvilex is clearly working on what is best for the Company and its shareholders with respect to the protocols and sites for advanced clinical trials, and will consult with the FDA and drug regulatory agencies in other countries prior to finalizing its decisions.

As Nuvilex management concludes all of the steps along the path to engaging in advanced clinical trials, and keeps investors apprised of its progress, shareholders will certainly be rewarded as these milestones are achieved.

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About Nuvilex, Inc. (OTCQB: NVLX): Nuvilex, Inc. has been a provider of all-natural products for many years, has expanded its company to increase its natural product based footprint through medical marijuana studies and is becoming an international biotechnology provider of live, therapeutically valuable, encapsulated cells and services for treatments, research and medicine. The Company's offerings will ultimately include cancer, diabetes and other clinical treatments using the company's natural product knowledge, product base, cell and gene therapy expertise, and live-cell encapsulation technology in addition to other new products currently under development. For more information visit:

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