Rock Creek Announces Update on Multi-Site Clinical Trial Studying Anatabloc® Formulation and Thyroid Health
Rock Creek Pharmaceuticals has additional information to report on its "ASAP" (Anatabloc Supplementation Autoimmune Prevention) thyroid study in humans. The 150 patient study 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", is fully enrolled and expected to complete in December of this year. The purpose of the study is to investigate the potential role of Anatabloc® formulations for nutritional supplementation in supporting the health of the human immune system. The ASAP thyroid study was planned as a human follow-up of a successful animal study, "Anatabine Ameliorates Experimental Autoimmune Thyroiditis, Endocrinology. 2012 Sep; 153 (9):4580-7." In the initial animal study, mice receiving anatabine had lower incidence and severity of experimental autoimmune thyroiditis, lower anti-thyroid antibody levels, and lesser declines in serum thyroxine as compared with untreated mice.
The research, which has moved from analyzing animals to analyzing humans, was designed to see if any of the changes observed in the mice could be observed in subjects with autoimmune thyroiditis. A per-protocol, scheduled, blinded (Treatment A v. Treatment B), interim look was recently completed, with data available for approximately 48 of the 165 randomized subjects at the time of the interim look.
The raters who reviewed the data agreed that there were sufficiently large enough inter-treatment differences, in both anti-thyroid antibody and interleukins, that the study was likely to reach its designed objectives. The statistical team that conducted the interim look recommended continuing the study as planned, and the Company anticipates completion and data base lock in December 2012.Dr. Curtis Wright, MD, MPH, Senior Vice President and Medical/Clinical Director of Rock Creek Pharmaceuticals Inc., stated, "I am greatly encouraged about the findings in the Flint study, which are consistent with other information about anatabine in diabetes, and the interim look in the Thyroid Study." Paul L. Perito, Esq., Rock Creek's Chairman and CEO commented, "We are pleased with the progress of the thyroiditis study and remain optimistic about the final analysis, which we anticipate will be concluded during the fourth quarter." Perito further commented, "Anatabloc ® is available in GNC stores in all 50 states and online at www.anatabloc.com." To date, 230 subjects have been screened for the ASAP study and enrollment is complete with 100 subjects having completed the study.