GLEN ALLEN, Va., Jan. 7, 2013 /PRNewswire/ -- Star Scientific, Inc. (NASDAQ: STSI) announced today the preliminary results of the Company's ASAP (Anatabloc Supplementation Autoimmune Prevention) Human Thyroid Study that analyzes the impact of anatabine dietary supplementation on thyroid health.
The study is a three-month, five-visit, double-blind, placebo-controlled study of the impact of anatabine dietary supplementation in humans with autoimmune disease of the thyroid. The study was conducted at nine sites and builds upon previous epidemiological and animal experimental studies. Initial results for all study subjects suggest that dietary supplementation with anatabine ameliorates the immune system's targeting of the thyroid gland in autoimmune thyroiditis.
Subjects in the study were screened initially to establish the presence of active autoimmune thyroid inflammation. Baseline thyroid sonography, thyroid antibody levels, and cytokine levels were collected from the subjects who were determined to have active autoimmune thyroid inflammation. Thyroid function tests and routine safety monitoring were also done in these subjects. Eligible subjects were enrolled in the study and then received weight-appropriate doses of anatabine or placebo, ranging from nine to twenty-four mg of the anatabine supplement or placebo per day. Subjects received treatment for three months, returning at four-week intervals for repeat laboratory testing and/or sonography of the thyroid.One-hundred forty-eight subjects completed the study, of which one-hundred forty six complied with all treatment, visits and required tests. The preliminary examination of the primary outcomes shows a clear and statistically significant difference in the treated group as compared to the placebo group by the end of the trial, with declines in anti-thyroglobulin antibody levels. Anatabine subjects also tended toward a reduction in thyroid gland vascularity on ultrasound relative to placebo. The full report of the study is still being completed and will soon be submitted for peer review. Therefore, it is unavailable at this time. However, these promising initial results prompted Curtis Wright, MD, MPH, Medical Director of Rock Creek Pharmaceuticals, to comment, "It is remarkable that dietary supplementation is able to help lower the thyroid antibody activity. To see antibodies that may have been elevated for years beginning to come down in a significant way after three months of supplementation is exciting. Given the rate of decline over three months, it is quite reasonable to expect that the effect may continue with longer use, which has already been observed in individual cases. I look forward to following subjects over a longer period in order to establish how profound and clinically meaningful the effect is going to be. The thyroglobulin levels in some patients returned entirely to normal in this three month study." Dr. Paul Ladenson, senior endocrinological consultant for the study, stated, "Data from this rigorously conducted, placebo-controlled, double blind trial show that anatabine-treated subjects had progressive decreases in circulating thyroglobulin antibody levels, which became significant by the end of the trial. Current treatment for autoimmune thyroiditis is limited to end-stage disease when irreversible gland damage necessitates lifelong thyroid hormone replacement. The prospect of a novel nutritional or pharmaceutical intervention that could preserve thyroid health represents an encouraging advance. Further clinical studies are now warranted." The title of the study is, "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 full study report will be available after all secondary analyses have been completed and is planned to be submitted for scientific presentation and publication later in the year.