Star Scientific and Rock Creek Pharmaceuticals Report on the Beneficial Nutritional Effects of Anatabine in an Animal Model of Ulcerative Colitis

GLEN ALLEN, Va., March 19, 2013 /PRNewswire/ -- Star Scientific, Inc. (NASDAQ: STSI), through its wholly owned subsidiary, Rock Creek Pharmaceuticals, Inc., announced today that it has received positive preliminary results from a study investigating the effects of anatabine in an animal model of idiopathic inflammatory bowel disease, Crohn's disease and ulcerative colitis.  This study, performed by researchers in the Department of Medicine at the University of Virginia, assessed the effects of anatabine administration on clinical and histologic manifestations of colitis in a mouse model of colonic inflammation that has many features of a major form of human inflammatory bowel disease.

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This animal model of inflammatory bowel disease, in which bowel inflammation is induced in mice by the administration of a chemical known as DSS (dextran sodium sulphate) in the drinking water, was chosen because it is a very well established and highly reproducible model of colonic inflammation. More importantly, this model allowed for an examination of the effect of anatabine on the development and severity of inflammation (colitis prevention), as well as on the recovery from inflammation and repair of tissue damage (colitis treatment).  

Preliminary results from the prevention phase of the study showed that animals given anatabine in their drinking water had a statistically significantly (p < 0.05) lower score in the primary clinical disease activity index as compared to the score of mice receiving only DSS.  The disease activity index is the summation of scores from three parameters assessed daily: weight loss, stool consistency, and blood in the stool (hematochezia).  Lower scores represent lower levels of disease activity.  Anatabine treatment significantly reduced diarrhea and watery stool during induction of the inflammatory condition.  Anatabine supplementation after inflammation was established was less conclusive because mice in both the anatabine and control groups decreased the amount of water they drank by almost 50% during the first few days of the recovery regimen.  Therefore, the amount of anatabine received by the anatabine treated group of mice was much lower than intended during recovery.

The initial results of this study suggest that anatabine dietary supplementation may prevent the recurrence (flare up) of ulcerative colitis or reduce the severity of symptoms in vulnerable individuals.  Although the results from the longer-term treatment phase of the study were inconclusive, the significant reduction in clinical manifestations of some features of bowel inflammation with preventative treatment suggests that anatabine supplementation may interfere with the excessive and prolonged production of inflammatory molecules that leads to these clinical outcomes.  Work at the University of Virginia is ongoing to determine whether anatabine administration interfered with the expression of pro-inflammatory cytokines and other markers of inflammation in gastrointestinal tissue samples.  Based on the initial primary results of this pre-clinical study, a study of the safety and effects of anatabine supplementation in human ulcerative colitis may be warranted.

Dr. Curtis Wright, Medical and Clinical Director of Rock Creek Pharmaceuticals, said, "Animal models of human disease are not always predictive of benefits in humans, but when individual patient reports are consistent with an animal model in a controlled laboratory study the findings reinforce each other. We provided the study materials and appropriate funding to the University of Virginia in support of the investigators' interest in this area, and are very pleased with the results, which are consistent with the individual case reports of benefit we have received from physicians and patients describing their experiences with Anatabloc®. We hope the University may consider that the time has come for a human clinical trial and we will follow their research closely."

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 and/or other studies, the challenges inherent in new product development initiatives, including the continued development and market acceptance of our nutraceutical dietary supplements products, the effect of any competitive 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, potential litigation by or against us and any governmental review of our products or practices, 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, 2012. 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, Inc. is a technology-oriented company with a mission to promote maintenance of a healthy metabolism and lifestyle. Through its wholly owned subsidiary, Rock Creek Pharmaceuticals, Star Scientific has been engaged in the manufacturing, sale, and marketing of two nutraceutical dietary supplements, a cosmetic facial cream, and the development of other nutraceuticals and pharmaceuticals. The company also continues to pursue the licensing of the technology behind its proprietary StarCured® curing process and its related products. 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, and an Executive, Scientific & Regulatory Affairs office in Washington, DC.

Contact:
Talhia T. Tuck
Vice President, Communications and Investor Relations
Star Scientific, Inc.
(202)887-5100
[email protected]

SOURCE Star Scientific, Inc.

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