Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced positive six month data from its double-blind placebo controlled Phase 2b study of PRX302 (study name: TRIUMPH) in patients with moderate to severe benign prostatic hyperplasia (BPH) a bothersome urologic condition that affects the quality of life of more than 50 million men worldwide. The study met its primary endpoint in January 2010 with a statistically significant improvement in International Prostate Symptom Score (IPSS) at Day 90 for patients treated with PRX302 versus placebo and requires additional patient assessments at six and twelve months in order to evaluate safety and the durability of response.
"The six month data from the TRIUMPH study continues to be impressive," said Dr. Fahar Merchant, President and Chief Executive Officer of Protox. "These data show a sustained improvement in all efficacy measures consistent with the long-term duration of effect observed in earlier studies. The continued increase in peak urine flow rate, or Qmax, was also remarkable and actually improved by an additional twenty percent when compared to Day ninety results. These data further our belief that PRX302 represents a considerable commercial opportunity".
"The TRIUMPH study continues to deliver exciting results indicating that a single administration of PRX302 to patients with BPH is well tolerated and provides symptomatic relief which is sustained for at least six months as evidenced by improved IPSS and QOL scores," said Dr. Mostafa M. Elhilali, OC, M.D., Ph.D. Stephen Jarislowsky Chair of Urology at McGill University and Co-Principal, Investigator. "The improvement in IPSS between treatment and placebo arms was a full point better at six months than at three months, though not statistically significant at six months due to an unexpected and noteworthy increase in the standard deviation of the placebo group. Furthermore, statistically significant improvement in peak urine flow rates demonstrates that PRX302 could offer a promising therapeutic option for patients with BPH."
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