GLEN ALLEN, Va., Aug. 23, 2012 /PRNewswire/ -- Star Scientific, Inc. (NASDAQ: STSI), through its wholly owned subsidiary Rock Creek Pharmaceuticals Inc., announced today that the Alzheimer's study of the company's dietary supplement Anatabloc® has screened and enrolled its first patient.
The Alzheimer's study, entitled, "A Three Month, Multi-Site, Double Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety, Tolerability and Potential Effect of the Dietary Supplement Anatabine in Subjects with Alzheimer's Disease," has its origins in basic research conducted at the Roskamp Institute (Sarasota, FL) and from case reports of beneficial effects of the company's dietary supplement Anatabloc® in individuals using the nutritional supplement under their physician's care.
The anatabine citrate used in Anatabloc® has been shown to be effective in lowering amyloid levels and other markers of inflammation in both tissue studies conducted in a laboratory setting and in animal research. In addition, Anatabloc® has been reported by others to be a useful nutritional supplement in Alzheimer's disease. The company received a patent for the synthesis of anatabine in June 2012, and a patent is pending for the Anatabloc® formulation. Preparations for the Alzheimer's study were extensive and included pharmacokinetic and tolerability studies, a review of the safety of Anatabloc® in other clinical trials that had the same usage level as in the Alzheimer's study, and a review of post-marketing reports for the Anatabloc® product itself.
The study will enroll 120 subjects with mild to moderate Alzheimer's disease and randomize these patients, who will then receive, on a blinded basis, either the active Anatabloc® supplement or a placebo. The subjects then will be monitored throughout the course of their assigned treatment to evaluate tolerability, safety, blood levels of inflammatory markers, and functional status. The intent of the study is to determine the safety of Anatabloc® in this population, and determine if there is evidence of a reduction in inflammatory markers or a change in functional status.
Rock Creek Pharmaceuticals received IRB approval of the first human clinical study of the safety and effects of nutritional supplementation with Anatabloc® in individuals with Alzheimer's disease in April 2012. The study is being conducted in conjunction with the Roskamp Institute of Sarasota, Florida, which has been acting as a research partner in assessing the impact of Anatabloc® on Alzheimer's. In addition to the Roskamp Institute site, the study also is being conducted at the Beaumont Hospital in Royal Oak, Michigan. Dr. Michael Mullan, M.D., Ph.D., President and CEO of the Roskamp Institute, commented: "We have known for a long time that Alzheimer's disease has a large inflammatory component. We also have observed the anti-inflammatory effects of anatabine (the active ingredient of Anatabloc®) in laboratory tests which is why we anticipate evidence of anti-inflammatory effects in this population."
Dr. Curtis Wright, M.D., M.P.H, Medical Director for Rock Creek Pharmaceuticals, said, "It is our profound hope that appropriate nutritional supplementation will be of some benefit to conventional care in the population suffering from this terrible disease. When we received the initial reports of beneficial responses in individuals, we realized that it was essential to determine if such reports represented a real beneficial nutritional effect. This study is the first one that will confirm or refute a significant nutritional effect of Anatabloc® in this population."
Individuals interested in the RCP-009 study can learn more by contacting the Roskamp Institute in Sarasota, Florida.
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, Inc. is a technology-oriented company with a mission to promote maintenance of a healthy metabolism, as well as to reduce the harm associated with the use of tobacco at every level. Over the last several years, through its wholly owned subsidiary, Rock Creek Pharmaceuticals, Star Scientific has been engaged in the manufacturing, sale, and marketing of two nutraceutical dietary supplements, and the development of other nutraceuticals and pharmaceuticals. The company also has continued to pursue the development, implementation, and licensing of the technology behind its proprietary StarCured® tobacco curing process, which substantially prevents the formation of carcinogenic toxins present in tobacco and tobacco smoke, primarily the tobacco-specific nitrosamines, or TSNAs and related low-TSNA dissolvable tobacco 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; Executive, Scientific & Regulatory Affairs offices in Bethesda, MD, and Washington, DC; and a manufacturing facility in Chase City, VA.
Talhia T. Tuck
Vice President, Communications and Investor Relations
Star Scientific, Inc.
SOURCE Star Scientific, Inc.