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Roskamp Institute Obtains IRB Approval for Multi-Site Human Clinical Trial with Rock Creek Pharmaceuticals RCP-006 Compound



2/28/2011 8:27:24 AM

GLEN ALLEN, Va., Feb. 28, 2011 /PRNewswire/ -- Rock Creek Pharmaceuticals, a wholly owned subsidiary of Star Scientific, Inc. (Nasdaq: CIGX) has been notified by the Roskamp Institute of Sarasota, Florida that the Institute has received institutional review board (IRB) approval to conduct a three-month, multi-site clinical trial with Rock Creek's RCP-006 nutritional supplement formula. The study (referred to as the "Flint Study"), will enroll approximately 200 subjects and begins with subject recruitment and enrollment. It will be centered in the Flint, Michigan area, where a number of physicians and surgeons have volunteered to enroll patients who meet the subject profile. The trial will examine the effect of RCP-006 on chronic inflammation in individuals who have elevated blood levels of C-reactive protein (CRP). CRP is a human serum protein that, when elevated, is an indicator of risk for a variety of diseases, and is a known marker for chronic inflammation. Clinical research has shown that certain forms of coronary artery and vascular diseases, and a number of autoimmune diseases (including diabetes and thyroid disease) all are linked by risk factors that include indications of chronic inflammation. Evidence of reduction in CRP levels in individuals at high risk for these conditions would be strong evidence that RCP-006 can be helpful in the nutritional management of these diseases. Factors related to nutritional supplementation are already known to impact human disorders involving chronic low-level inflammation. For example, aspirin, weight loss, exercise and healthy dietary practices reduce these inflammatory markers and are known to reduce cardiovascular and/or stroke risk. There is intense focus in the scientific community on the search to identify compounds that can significantly reduce CRP levels and the underlying inflammatory process they signal.

(Logo: http://photos.prnewswire.com/prnh/20090317/STARSCIENTIFICLOGO )

Curtis Wright, MD, MPH, Senior Vice President of Rock Creek Pharmaceuticals, commented: "Researchers have published studies for years showing that good nutrition and good health behaviors can have powerful effects on cardiovascular and neurovascular health, but the mechanisms that achieve these effects are still under active research. It is an exciting indicator of progress that Roskamp is exploring the link between our nutritional supplements and balancing inflammation in both the laboratory and clinical settings. We believe this may provide both further understanding of the existing data and an effective way for physicians to nutritionally address reducing the risk associated with a variety of conditions."

The Roskamp Institute also recently has reported new data on their website, http://www.rfdn.org/inflammaging.html, that describes the progress in their study of the effects of RCP-006. In a section that describes "inflammaging," the Institute indicates that the inflammatory response of human blood to a bacterial toxin (LPS) is shown to be markedly reduced by RCP-006. These results hold promise for the control of the inflammation that plays a role in Alzheimer's disease, and they also spurred the upcoming research to explore more broadly the ability of this compound to regulate inflammation.

Certain statements in this press release other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have tried, whenever possible, to identify these forward-looking statements using words such as "anticipates," "believes," "estimates," "continues," "likely," "may," "opportunity," "potential," "projects," "will," "expects," "plans," "intends" and similar expressions to identify forward-looking statements, whether in the negative or the affirmative. These statements reflect our current beliefs and are based on information currently available to us. Accordingly, such forward-looking statements involve known and unknown risks, uncertainties and other factors which could cause our actual results, performance or achievements to differ materially from those expressed in, or implied by, such statements. These risks, uncertainties, factors and contingencies include, without limitation, the challenges inherent in new product development initiatives through Star Tobacco and Rock Creek, the uncertainties inherent in the progress of scientific research, our ability to raise additional capital in the future that is necessary to maintain our business, potential disputes concerning our intellectual property, risks associated with litigation regarding such intellectual property, uncertainties associated with the development, testing and regulatory approvals of our low-TSNA tobacco, related tobacco products and pharmaceutical and nutraceutical products , market acceptance of our new smokeless tobacco products and nutraceutical and pharmaceutical products, competition from companies with greater resources than us, our dependence on key employees and on our prior strategic relationships with Brown & Williamson Tobacco Corporation in light of its combination with R.J. Reynolds Tobacco Company, Inc. Although the Company believes the expectations reflected in such forward-looking statements are based on reasonable assumptions, it can give no assurance that the expectations will be attained or that any deviation will not be material. See additional discussion under "Risk Factors" in the Company's Annual Report on Form 10-K as filed with the SEC on March 16, 2010, and other factors detailed from time to time in the Company's other filings with the SEC, available at www.sec.gov. All information in this release is current as of this date, and the Company undertakes no obligation to update or advise upon any such forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

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, D.C. 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. See Star's website at: http://www.starscientific.com

Contact:

Sara Troy Machir - Vice President, Communications & Investor Relations

smachir@starscientific.com

301-654-8300



SOURCE Star Scientific, Inc.


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