|Star Scientific Announces Successful First Look at the "Flint" CRP Human Study and Provides Updated Report on ASAP Human Thyroid Study|
GLEN ALLEN, Va.,
"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
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®
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
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