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.
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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.
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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
SOURCE Star Scientific, Inc.