Star Scientific, Inc. through Rock Creek Pharmaceutical, Inc. announced that it has received positive preliminary results from a study investigating the effects of anatabine in an animal model of idiopathic inflammatory bowel disease, Crohn's disease and ulcerative colitis. This study, performed by researchers in the Department of Medicine at the University of Virginia, assessed the effects of anatabine administration on clinical and histologic manifestations of colitis in a mouse model of colonic inflammation that has many features of a major form of human inflammatory bowel disease. This animal model of inflammatory bowel disease, in which bowel inflammation is induced in mice by the administration of a chemical known as DSS (dextran sodium sulphate) in the drinking water, was chosen because it is a very well established and highly reproducible model of colonic inflammation.

More importantly, this model allowed for an examination of the effect of anatabine on the development and severity of inflammation (colitis prevention), as well as on the recovery from inflammation and repair of tissue damage (colitis treatment). Preliminary results from the prevention phase of the study showed that animals given anatabine in their drinking water had a statistically significantly (p < 0.05) lower score in the primary clinical disease activity index as compared to the score of mice receiving only DSS. The disease activity index is the summation of scores from three parameters assessed daily: weight loss, stool consistency, and blood in the stool (hematochezia).

Lower scores represent lower levels of disease activity. Anatabine treatment significantly reduced diarrhea and watery stool during induction of the inflammatory condition. Anatabine supplementation after inflammation was established was less conclusive because mice in both the anatabine and control groups decreased the amount of water they drank by almost 50% during the first few days of the recovery regimen.

Therefore, the amount of anatabine received by the anatabine treated group of mice was much lower than intended during recovery. The initial results of this study suggest that anatabine dietary supplementation may prevent the recurrence (flare up) of ulcerative colitis or reduce the severity of symptoms in vulnerable individuals. Although the results from the longer-term treatment phase of the study were inconclusive, the significant reduction in clinical manifestations of some features of bowel inflammation with preventative treatment suggests that anatabine supplementation may interfere with the excessive and prolonged production of inflammatory molecules that leads to these clinical outcomes.

Work at the University of Virginia is ongoing to determine whether anatabine administration interfered with the expression of pro-inflammatory cytokines and other markers of inflammation in gastrointestinal tissue samples. Based on the initial primary results of this pre-clinical study, a study of the safety and effects of anatabine supplementation in human ulcerative colitis may be warranted.