Rock Creek Pharmaceuticals Reports First Clinical Trial Showing Anatabloc(TM) Lowers Chronic Inflammation Measured by CRP Blood Levels in Humans
 Note: Anatabine blood levels were not zero for non-users due to the presence of anatabine in tobacco
GLEN ALLEN, VA--(Marketwire -01/30/12)- Rock Creek Pharmaceuticals, Inc., a subsidiary of Star Scientific, Inc. (NASDAQ: CIGX - News), has completed the first successful human clinical trial showing that Anatabloc™, the dietary supplement developed by Rock Creek to provide anti-inflammatory support, lowers C-reactive protein (CRP) levels in subjects' blood. CRP is a molecule produced by the liver in response to an inflammatory signal, and is a marker for inflammation. The company is today reporting initial results from Phase 2 of the RCP-006 study titled "A Single Center, Single-Blind, Randomized, Crossover Pilot Study to Evaluate the Safety and Efficacy of Anatabloc™, a Dietary Supplement, in Reducing the Urge to Smoke in Daily Smokers, Followed by an Open-Label Extension Period." The trial consisted of 105 subjects, all of whom were smokers and 79% of whom were overweight or obese. Research increasingly links inflammation to a variety of diseases such as Alzheimer's disease, thyroiditis and diabetes, as well as cardiovascular disease.
Phase 1 of the study was a one-day trial to assess whether Anatabloc™ was as successful as CigRx®, the company's other dietary supplement, in reducing the urge to smoke, and results showed that CigRx® and Anatabloc™ were equally effective. Phase 2 of the study was an open-label extension in which subjects were instructed to take two Anatabloc™ tablets three times per day for two weeks. Study site visits were scheduled at the end of each one-week period so that subjects could complete study assessments and for collection of blood and breath samples. In Phase 2, subjects continued to smoke, but took 6 tablets per day of Anatabloc™. Phase 3, a longer open-label extension, is ongoing.
Phase 2 data analysis examined the CRP and anatabine levels in the subjects' blood, first to establish a baseline, and then to assess levels with Anatabloc™ dosing:
The graph shown on the right illustrates that CRP levels in subjects with dose-appropriate anatabine levels were about 30% lower than CRP levels among those with low anatabine levels. These levels were documented despite subjects' continued smoking, and at a relatively low dose of anatabine by bodyweight in some very heavy subjects (79% were overweight or obese).
Paul L. Perito, Rock Creek's Chairman and CEO, commented, "These findings are encouraging as well as fascinating. This clinical trial clearly demonstrates there is a real and significant effect on CRP levels in blood from nutritional supplementation with Anatabloc™." Curtis Wright MD/MPH, Senior VP for Rock Creek Pharmaceuticals, commented, "CRP is a highly variable measure that is difficult to work with. I am very pleased that we were able to use modern analyses to understand this complex data, thanks to analytical assistance from the Roskamp Institute. I am amazed that these low doses of Anatabloc™ had an effect in this population, which is at such high risk due to obesity and smoking."
Anatabloc™ was introduced in August, 2011 and has been available for purchase via the company's dedicated marketing program that includes a toll-free telephone ordering system, a dedicated product website and one e-commerce web portal. Visit www.anatabloc.com to learn more about Anatabloc™ and inflammation |
