Star Scientific Announces Successful First Look at the "Flint" CRP Human Study and Provides Updated Report on ASAP Human Thyroid Study
GLEN ALLEN, Va., Oct. 24, 2012 /PRNewswire/ -- Star Scientific, Inc. (NASDAQ: STSI), announced today that the Roskamp Institute has reported positive findings in its analysis of 100 subjects who completed the "Flint" CRP study that analyzes the effects of dietary supplementation with Anatabloc® in humans. The Company is also reporting additional information relating to its ASAP human thyroid study.
"Flint" CRP Study
The "Flint" study titled, "A Single-blind, Multi-site Trial of the Dietary Supplement Anatabine (RCP006) to Determine the Effects on Peripheral Markers of Inflammation in Patients with Elevated Levels of C-reactive Protein (CRP)", is a multi-site study of the safety, tolerability, dosing, and biological effects of the anatabine citrate used in Rock Creek Pharmaceutical's Anatabloc® product. Subjects in the study are individuals with high levels of C-reactive protein (CRP) in the blood, which is a marker of systemic inflammation in a number of common medical conditions. The subjects were screened for eligibility and then were studied for three months. In the first month they were given placebo, in the second month they were given the Anatabloc® supplement, and in the third month they were given placebo again. Blood samples were taken at the beginning of the study and also were taken after each treatment period. The blood samples were analyzed for CRP, anatabine, multiple markers of inflammation referred to as interleukins (cytokines), as well as routine clinical labs for safety. The intent of the study is to determine if the Anatabloc® supplement is helpful in lowering CRP.
The committee reviewing the data found that the administered doses of anatabine were safe, well-tolerated, and showed clear evidence of a biological effect on CRP and the immune system, as manifested by CRP and an inflammatory marker called Tumor Necrosis Factor Alpha (TNF-alpha). The committee also found a signal that the supplement may have an important effect in the most common form of adult onset diabetes. Anatabine citrate, the active ingredient in Anatabloc®, is found in common food plant species and is a natural compound that activates the Alpha7 nicotinic acetylcholine receptor. Alpha7 receptors are believed to be important in a number of inflammatory conditions, including the characteristic systemic inflammation seen in diabetes.
The subjects who showed relative reductions in CRP were diabetics on metformin, the most common drug used to treat diabetes. The diabetics were twice as likely to have a reduction in CRP levels, as compared with other subjects in the "Flint" study who had other non-diabetes medical disorders. After one month of supplementation, CRP levels dropped in 26% of the subjects with diabetes, compared with a drop in CRP levels in 12% of the general trial population of subjects who did not have diabetes. The goal of the study was to find specific sub-populations in which the Anatabloc® supplement might be of benefit; therefore, this finding, though based on a small number of diabetics (18 in the total study population), is very encouraging. The investigators are currently evaluating whether to modify the rest of the study or conduct a study focused on diabetes.
Elevated CRP is predictive in other studies for the onset of both metabolic syndrome as well as overt diabetes, and elevated CRP is a significant risk factor for cardiovascular disease both in diabetics and non-diabetics. Lowering CRP would be strong evidence of a potential benefit in reducing the inflammatory component in adult onset diabetes, an epidemic problem in the United States.
Dr. Michael Mullan, MD, PhD, of the Roskamp Institute that sponsored the study, said, "We are still looking at the data to define which interleukins are most strongly affected, but when we conducted the CRP breakout analysis by disease, the late onset diabetics showed a strong statistical trend to have lower CRP with anatabine treatment compared to the non-diabetics. It will take more work beyond this interim look to confirm this in a larger sample."
464 subjects have been screened for the "Flint" study, and 117 subjects have completed the study.
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.
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, the challenges inherent in new product development initiatives, including the continued development and market acceptance of our nutraceutical and low-TSNA tobacco 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, including with respect to our nutraceutical and low-TSNA tobacco products, 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, 2011. 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, as well as to reduce the harm associated with the use of tobacco at every level. Over the last several years, through its wholly owned subsidiary, Rock Creek Pharmaceuticals, Star Scientific has been engaged in the manufacturing, sale, and marketing of two nutraceutical dietary supplements, and the development of other nutraceuticals and pharmaceuticals. The company also has continued to pursue the development, implementation, and licensing of the technology behind its proprietary StarCured® tobacco curing process, which substantially prevents the formation of carcinogenic toxins present in tobacco and tobacco smoke, primarily the tobacco-specific nitrosamines, or TSNAs and related low-TSNA dissolvable tobacco 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; Executive, Scientific & Regulatory Affairs offices in Bethesda, MD, and Washington, DC; and a manufacturing facility in Chase City, VA.
Talhia T. Tuck
Vice President, Communications and Investor Relations
Star Scientific, Inc.
(202) 887-5100 firstname.lastname@example.org
SOURCE Star Scientific, Inc.