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Star Scientific and Rock Creek Pharmaceuticals Announce the Publication of a Peer-Reviewed Article about the ASAP Clinical Trial Showing Immune System Support in Hashimoto's Thyroiditis
Date:10/31/2013

GLEN ALLEN, Va., Oct. 31, 2013 /PRNewswire/ -- Star Scientific, Inc. (NASDAQ: STSI) and Rock Creek Pharmaceuticals, Inc. announce the publication of a peer-reviewed article reporting results from the Company's ASAP (Anatabloc® Supplementation Autoimmune Prevention) clinical trial in patients with Hashimoto's thyroiditis. The article, entitled, "Anatabine supplementation decreases thyroglobulin antibodies in patients with chronic lymphocytic autoimmune (Hashimoto's) thyroiditis:  A randomized controlled clinical trial", was published October 31, 2013 as a Brief Report in The Journal of Clinical Endocrinology & Metabolism (JCEM).  JCEM is a publication of The Endocrine Society, and is described on their website as, "the world's leading peer-reviewed journal for clinical research and practice reviews in endocrinology."

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The ASAP study was a three-month, IRB-approved, five-visit, double-blind, randomized, placebo-controlled, multi-site study evaluating the impact of anatabine dietary supplementation in patients with Hashimoto's thyroiditis, one of the most common autoimmune diseases and a frequent cause of thyroid dysfunction.  A total of 146 patients, 70 receiving anatabine and 76 placebo, completed the study at nine sites in the United States. Anatabine lozenges (9-24 mg per day based upon body weight) or placebo, each containing vitamins A and D3, were administered orally, three times a day for three months, with patients returning at four-week intervals for laboratory testing and/or ultrasonography of the thyroid.

The primary outcomes tested whether dietary supplementation with anatabine ameliorates the immune system's targeting of the thyroid gland in cases of autoimmune thyroiditis.  The results showed that anatabine reduced the patients' immune reaction against their own thyroid gland.  Patients taking anatabine had a significantly greater reduction from baseline in serum thyroglobulin antibody levels compared to patients on placebo (p= 0.027).  Similarly, more patients in the anatabine group had a greater than 20% drop in thyroglobulin antibodies than patients on placebo (p=0.023).  Finally, the percentage of patients on anatabine with reductions in thyroglobulin antibodies of at least 25, 50, 75, or 100 WHO units was significantly greater than that of patients on placebo (all p < 0.05 at all cut-off levels). There were no significant changes or treatment group differences in serum thyroid function tests, thyroperoxidase antibody, inflammatory biomarkers, or ultrasonography measures.

Overall, as the study concludes, the anatabine supplement was safe and well tolerated, although it was associated with more minor adverse events on initial dose adjustment.  The most common MedDRA adverse events upon starting anatabine supplementation were mild dizziness (36%), nausea (8%), headaches (7%), and paresthesia (7%); most of the events were resolved with simple dose adjustment. Very few patients withdrew from the study due to adverse events (7 on anatabine and 1 on placebo). There were no significant abnormalities in clinical laboratory values attributed to anatabine, and no clinically significant effects of supplementation, either with anatabine or placebo, on vital sign measures.

Curtis Wright, MD, MPH, Medical Director of Rock Creek Pharmaceuticals, commented, "The concept for this clinical trial originated after receiving reports from individuals that the addition of anatabine, a Solanaceous alkaloid, to their diet improved their thyroid inflammatory disease.  The idea was supported by multiple recent epidemiological studies showing that exposure to Solanaceous alkaloids or other compounds from tobacco, had 'beneficial effects' in Hashimoto's thyroiditis.  Finally, an experimental study in mice reported that anatabine ameliorates disease in a model of Hashimoto's thyroiditis.  The results of the trial show that dietary supplementation with anatabine induces a statistically significant reduction in thyroid autoimmunity.  We believe that continued supplementation (beyond the three months of this study) will show a progressive improvement in overall autoimmune responses."

The "Early Release" manuscript is currently available and may be obtained by clicking the following link: http://jcem.endojournals.org/content/early/recent

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, any governmental review of our products or practices and the outcome of the ongoing investigations 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 and our quarterly reports  on Form 10-Q for the quarters ended March 31, 2013 and June 30, 2013.  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, cosmetic products, 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
ttuck@starscientific.com

 


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