PurGenesis Initiates Phase 2a Trial for the Treatment of Mild-to-Moderate Distal Ulcerative Colitis
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PurGenesis Technologies, Inc., announced that it has initiated a Phase 2a clinical trial to evaluate the safety, tolerability, and efficacy of PUR0110 in patients with active mild-to-moderate distal ulcerative colitis.
The Phase 2a study is an exploratory multicenter, randomized, double-blind, dose-ranging, parallel-group, placebo-controlled trial that is designed to further evaluate the safety and tolerability of PUR0110, a rectal enema treatment in development for patients with active mild-to-moderate distal ulcerative colitis as its primary objective. The study is also designed to evaluate the effectiveness and the effect of PUR0110 on specific clinical endpoints. Twenty-four (24) patients will be randomized to receive either one of 3 doses of PUR0110 or placebo, administered once-daily for 14 days.
“The strong anti-inflammatory and immunomodulatory effects of PUR0110 observed in previous in vitro and in vivo pharmacology studies and the impressive safety profile of PUR0110 in the recently completed Phase 1 study in healthy volunteers cumulatively provides a well-founded rationale for this PUR0110 Phase 2a trial. We look forward to the results of this exploratory trial at the end of this year” said Mr. Eugene Melnyk, Chairman of the Board; founder and former Chairman and CEO of Biovail Corporation (Symbol BVF: NYSE, TSE).
“Our clinical program around PUR0110 is expanding as this therapeutic product is moving into more advanced stages of clinical development. This Phase 2a study represents the first of several new clinical trials for this innovative botanical drug that we hope to announce over the course of 2010," added Dr. André P. Boulet, president & COO of the company.
The primary endpoint of this safety and tolerability study is the frequency of adverse events. The secondary endpoints include the clinical response rate, clinical remission rate, changes from baseline in the overall disease activity index (or modified Mayo score) and in its sub-scores, and change from baseline in the Inflammatory Bowel Disease Questionnaire score. The study will compare these endpoints in patients receiving PUR0110 rectal enema to those in the patients receiving placebo.
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