Today, through its wholly owned subsidiary, Rock Creek Pharmaceuticals, Star Scientific announced it has received positive preliminary results from an investigational study of the effects of anatabine in an animal model of idiopathic inflammatory bowel disease, Crohn's disease, and ulcerative colitis. Performed by researchers in the University of Virginia's Department of Medicine, the study assessed the effects of anatabine administration on clinical and histologic manifestations of colitis in a mouse model of colonic inflammation, which possessed many features of a major form of human inflammatory bowel disease.
The animal model of inflammatory bowel disease - in which bowel inflammation is created in mice through administering a chemical known as DSS (dextran sodium sulphate) in their drinking water - was chosen as a well-established and highly reproducible colonic inflammation model. Further, the model enabled an examination of the effect of anatabine on inflammation's development and severity (colitis prevention) and on recovery from inflammation and the repair of tissue damage (colitis treatment).
It was shown in preliminary results from the prevention phase that animals given anatabine in their drinking water statistically had a score significantly lower (p < 0.05) in the primary clinical disease activity index than the mice receiving only DSS. The disease activity index is the summation of scores from three parameters assessed on a daily basis: weight loss, stool consistency, and hematochezia (blood in the stool). Lower scores demonstrate lower levels of disease activity. Diarrhea and watery stool were significantly reduced during induction of the inflammatory condition with anatabine treatment. It was established that anatabine supplementation after inflammation was less conclusive, as mice in both the anatabine group and the control groups decreased the amount of water they drank by almost half during the first few days of the recovery regimen. The amount of anatabine received by the anatabine-treated set of mice was, therefore, much lower than intended during recovery.
This study's initial results imply that anatabine dietary supplementation may prevent flare up of ulcerative colitis or reduce the severity of symptoms in vulnerable individuals. Though results from the longer-term treatment phase were inconclusive, the marked reduction in clinical manifestations of some features of bowel inflammation with preventative treatment implies that anatabine supplementation may interfere with the excessive and prolonged production of inflammatory molecules leading to these clinical outcomes.
The work being conducted 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. A study of the safety and effects of anatabine supplementation in human ulcerative colitis may be warranted, based on the initial primary results of this preclinical study.
"Animal models of human disease are not always predictive of benefits in humans, but when individual patient reports are consistent with an animal model in a controlled laboratory study, the findings reinforce each other," said Dr. Curtis Wright, medical and clinical director of Rock Creek Pharmaceuticals. "We provided the study materials and appropriate funding to the University of Virginia in support of the investigators' interest in this area and are very pleased with the results, which are consistent with the individual case reports of benefit we have received from physicians and patients describing their experiences with Anatabloc. We hope the University may consider that the time has come for a human clinical trial, and we will follow their research closely."
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