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Roskamp Institute Reports Beneficial Effects of Nutritional Supplementation with Anatabine in an Animal Model of Multiple Sclerosis
Date:5/8/2012

GLEN ALLEN, Va., May 8, 2012 /PRNewswire/ -- Star Scientific, Inc. (NASDAQ: CIGX) through its wholly owned subsidiary, Rock Creek Pharmaceuticals Inc., announces that it has received important new research findings from its research partner, The Roskamp Institute of Sarasota, Florida. The Institute has completed a successful animal study of nutritional supplementation with Rock Creek's specially formulated anatabine (patent pending), in an animal model of multiple sclerosis. The Roskamp Institute has previously reported on a successful study in a mouse model of Alzheimer's disease using nutritional supplementation with a specially formulated version of Anatabloc® (patent pending).

In this report, entitled "Preliminary results of the treatment of a mouse model of Multiple Sclerosis with anatabine," the researchers at Roskamp describe how they assessed the effects of nutritional supplementation of the animal's diet with an animal formulation of anatabine in EAE (experimental autoimmune encephalomyelitis). This condition is induced by vaccinating mice with myelin which induces an autoimmune reaction. As a consequence, there is a severe inflammatory process in the brain, which has the effect of destroying neurons and causing progressive paralysis. In this regard, the disease model looks very similar to that which occurs in human multiple sclerosis. Dietary supplementation with anatabine resulted in a dramatic reduction in the rate of paralysis of hind limbs [see figure 1].

In addition to the better motor performance of the mice, there was evidence of suppression of the normal inflammatory response that accompanies neuronal destruction in this model. In the affected animals that did not receive supplementation with an anatabine formulation, the spleen pro-inflammatory molecules, such as IFN-gamma, IL-8, IL-6 and TNF-alpha (which are all significantly raised by the induction of inflammation), were markedly elevated relative to control animals. In the mice that received the anatabine supplement, these inflammatory molecules were all reduced to normal levels [see figure 2]. These preliminary data all suggest the company's specially formulated anatabine supplement has a highly beneficial effect in this model of MS.

The report is available on the Roskamp Institute website at http://www.rfdn.org/ms_anatabine.html.

"These are encouraging results that show biological activity in a relevant animal model," said Dr. Curtis Wright, Senior Vice President and Medical Director of Rock Creek Pharmaceuticals. "Roskamp has shown that supplementing the diet of the test mice with an animal version of our specially formulated human anatabine product interfered with the myelin injections triggering the autoimmunity and inflammation that cause the paralysis. Not only did they show a reduction, prevention or delay in paralysis, but they showed a reduction in pro-inflammatory markers as well. The placebo mice rapidly developed inflammation and paralysis; the mice receiving anatabine dietary supplementation were less severely affected."

Rock Creek Pharmaceuticals and the Roskamp Institute have worked collaboratively on research relating to the company's anatabine compound for a number of years, occasioned by the Institute's interest in the effect of the compound on immune system support and inflammation in the nervous system. Inflammation and the proper or aberrant functioning of the immune system is a critical factor in a number of neurological disorders studied by the Institute, and using nutritional means in helping the immune system regain its natural balance is one path toward supporting current medical treatments for such conditions.

Paul L. Perito, Rock Creek's Chairman and CEO stated, "We continue to be impressed by the creative scientific insights and progress of the research team headed by Michael Mullan MD, PhD, along with his colleagues Drs. Crawford and Paris at the Roskamp Institute. We look forward to the development of this encouraging hypothesis and the initiation of human clinical trials when appropriate."

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Certain statements contained in this release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements identified by words such as "believes," "expects," "anticipates," "estimates," "intends," "plans," "targets," "projects" and similar expressions. The statements in this release are based upon the current beliefs and expectations of our company's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Numerous factors could cause or contribute to such differences, including, but not limited to, results of clinical trials, the challenges inherent in new product development initiatives, including the continued development and market acceptance of our nutraceutical and low-TSNA tobacco products, our ability to license and protect our intellectual property, our ability to raise additional capital in the future that is necessary to maintain our business, changes in government policy and/or regulation, including with respect to our nutraceutical and low-TSNA tobacco products, as well as other risks discussed from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our annual report on Form 10-K for the fiscal year ended December 31, 2011. We undertake no duty to update any forward-looking statement or any information contained in this press release or in other public disclosures at any time.

About Star Scientific
Star Scientific is a technology-oriented company with a mission to reduce the harm associated with tobacco at every level. It is engaged in the development of dissolvable smokeless tobacco products that deliver fewer carcinogenic toxins, principally through the utilization of the innovative StarCured® tobacco curing technology. Its subsidiary, Rock Creek Pharmaceuticals, Inc., is involved in the development of nutraceuticals as well as products to address neurological and mood disorders. Rock Creek Pharmaceuticals has scientific and research offices in Gloucester, MA, and a regulatory office in Washington, DC. Star Scientific has a Corporate and Sales Office in Glen Allen, VA, an Executive, Scientific & Regulatory Affairs office in Bethesda, MD, and a manufacturing facility in Chase City, VA.

Contact:

Talhia T. Tuck
Vice President, Communications and Investor Relations
Star Scientific, Inc.
(301) 654-8300
ttuck@starscientific.com

or

Curtis Wright, IV, MD/MPH
Medical/Clinical Director and
Sr. Vice President of Rock Creek Pharmaceuticals, Inc.
(978) 283-1372

 


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