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."
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.