Rock Creek Pharmaceuticals Announces Initiation of Second Multi-Site Clinical Trial; Protocol to Study an Anatabloc(TM) Formulation and Thyroid Health

Published: Feb 09, 2012

GLEN ALLEN, VA--(Marketwire - February 09, 2012) -

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Star Scientific (NASDAQ: CIGX) subsidiary, Rock Creek Pharmaceuticals, is pleased to announce IRB approval, and successful identification and selection of five clinical sites in Texas, Illinois and Florida for its upcoming "ASAP" (Anatabloc Supplementation Autoimmune Prevention) thyroid study. The 120-patient study is titled "A Multi-Site, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Potential Effects of the Dietary Supplement Anatabine on Antithyroid Autoantibodies and Thyroid Function in Subjects with Autoimmune Thyroiditis." The study's purpose is to investigate the potential role for nutritional supplementation with an Anatabloc™ formulation in supporting immune health. Rock Creek developed the dietary supplement, brand-named Anatabloc™, which is available for purchase via a dedicated product website and through GNC's Internet storefront.

The nutritional study, which focuses on individuals at risk for inflammatory damage to the thyroid (Hashimoto's thyroiditis), was developed by a team of respected researchers to ensure the scientific quality of the evidence obtained in the study. The ASAP study is expected to be conducted during spring and summer 2012, and an interim look at the data currently is projected for mid-year. This is the second large, multi-site, double-blind, placebo-controlled study involving an Anatabloc™ formulation: the Roskamp Institute is conducting the currently enrolling Flint study at sites in Michigan and Florida. The company anticipates a mid-year look at interim data from that study as well.

Rock Creek last week announced its partnership with GNC for Anatabloc™ purchasing through GNC's web-based storefront. Anatabloc™, a dietary supplement, was designed to provide anti-inflammatory support by leveraging the body's own process in combination with supplementation from the product's active dietary ingredients, anatabine citrate and Vitamins A and D3. Excessive inflammation is associated with a variety of autoimmune conditions, as well as athletic and work-out injuries. Anatabloc™ was introduced in August 2011 through a dedicated product website, and shortly after launch it also became available for purchase via the Amazon.com portal.

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, the challenges inherent in new product development initiatives, including the continued development and market acceptance of our nutraceuticals, 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 nutraceuticals, 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, 2010. 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, 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.