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(TM), 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(TM) was as successful as CigRx(R), the company's other dietary supplement, in reducing the urge to smoke, and results showed that CigRx(R) and Anatabloc(TM) were equally effective. Phase 2 of the study was an open-label extension in which subjects were instructed to take two Anatabloc(TM) 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(TM). 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(TM) 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(TM)." 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(TM) had an effect in this population, which is at such high risk due to obesity and smoking."