PurGenesis announces positive results from Phase I clinical trial of PUR0110 for ulcerative colitis

PurGenesis Technologies Inc. (PurGenesis) announced today positive results from a Phase I clinical trial on PUR0110, the Company's lead investigational new drug for the treatment of ulcerative colitis. This successful trial was designed to evaluate the safety and maximum tolerated dose of PUR0110.

"The results of this study are very encouraging and demonstrate that PUR0110, a botanical drug product formulated as a rectal enema, can be safely administered in patients with ulcerative colitis," said Eugene Melnyk, Chairman of the Board.

PUR0110 is a botanical drug that modulates both the TNF-alpha/Il-10 ratio and interleukin 1b levels. These cytokines orchestrate the development of chronic inflammation in ulcerative colitis, psoriasis, rheumatoid arthritis and other inflammatory disorders.

"These safety data paved the way for the initiation of our Phase II program in the ulcerative colitis patient population," added Dr. André P. Boulet, President and Chief Operating Officer. "The results are particularly remarkable as PUR0110 modulates several pro- and anti-inflammatory cytokines which have been, to-date, the targets of only expensive biologics. In March, we received regulatory approval to initiate a Phase IIa clinical study in patients with ulcerative colitis. Patient recruitment is expected to be initiated in June, 2010," concluded Dr Boulet.

Trial Design

The Phase I trial was a randomized, double-blind, placebo-controlled, single-ascending dose, safety, tolerability and maximum tolerated dose (MTD) study of PUR0110 rectal enema in 24 normal healthy volunteers. Eligible subjects were randomized into 4 cohorts of 6 subjects each. Within each cohort, 4 subjects were randomized to receive PUR0110 rectal enema and 2 subjects to receive placebo enema as follows: Cohort No.1: 187.5 mg; Cohort No.2: 375 mg; Cohort No.3: 750 mg; and Cohort No.4: 1500 mg. All doses were administered intra-rectally, as single doses reconstituted in 60 g of vehicle, at bedtime. Flexible sigmoidoscopy and biopsy were performed on each subject pre-dose and 9 hours post-dosing.

No dose-limiting toxicities or safety signals were detected. No treatment-related adverse events were reported. Flexible sigmoidoscopy and biopsy revealed no visible or histological local mucosal tissue injury in the rectum and sigmoid colon post-dosing.

PUR0110 was safe and well tolerated.