The trial will evaluate the efficacy of PRX302 versus placebo using the optimal treatment volume established in the open-label Phase II study results announced in November, 2008.
The trial’s primary endpoint will be to determine efficacy of PRX302 as demonstrated by a statistically significant change in international prostate symptom score from baseline when compared to placebo. Secondary endpoints will be the measurement in change from baseline of the quality of life score, peak urinary flow rate and post-voiding residual urine volume when compared to placebo.
The trial will also continue to assess safety and tolerability of PRX302. Results from the three month follow-up period of the Phase II study released in November, 2008 were very positive, with PRX302 demonstrating significant symptomatic relief while maintaining an excellent safety profile in men with moderate to severe benign prostatic hyperplasia (BPH).
In addition, 12 month follow-up results from the Phase I BPH study, completed in October 2008, indicated that PRX302 continues to show durable therapeutic benefit for at least one year following a single treatment.
Fahar Merchant, president and CEO of Protox, said: Results from our open-label Phase II study demonstrated that PRX302 has the potential to establish a new standard of care for the treatment of BPH. With results from Triumph expected in the second half of 2009, we are confident this study will validate the value of PRX302 to our potential partners, and most importantly, patients suffering from BPH.