Star Scientific, Inc. announced 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.

148 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. 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.