Protox Therapeutics reports positive data from Phase II BPH trial

Fri. September 11, 2009; Posted: 01:07 PM

Sep 11, 2009 (Datamonitor via COMTEX) -- PTXRF | Quote | Chart | News | PowerRating -- Protox Therapeutics, a Canadian biopharmaceutical company, has reported positive 12 month data from its open-label Phase II study of PRX302 in males with moderate to severe benign prostatic hyperplasia or BPH.

According to Protox, the study results indicate that those patients who received an optimal dose of PRX302 continued to demonstrate significant symptomatic relief at 12 months following a single treatment.

In this Phase II open-label volume optimization study, 13 of the 18 patients received the optimum PRX302 dosing of (greater than)-1ml per deposit. A total of 11 of the 13 patients were evaluable at 12-months and continued to show a statistically significant and sustained improvement in international prostate symptom score (IPSS) of 12.1 points (p= 0.0003) representing a 55% improvement when compared to screening.

In addition to IPSS, quality of life scores improved significantly by an average of 3.18 points or 67% (p(less than)0.0001) at 12 months post-treatment. Furthermore, prostate volume at 12 months post-treatment decreased significantly by 29% (p=0.02), the company said.

Finally, the average maximum urine flow rate increased from 10.7ml/sec at screening to 15.2 ml/sec at 12 months for a 42% improvement in patients receiving the optimum dose. No safety issues were identified in this study, as increasing volumes of PRX302 were seen to be well tolerated, the company added.

Fahar Merchant, president and CEO of Protox, said: "We are very excited to see a 12 point improvement in IPSS in this patient group even after 12 months following a single treatment. This level of symptomatic improvement is almost double that seen with oral therapies and comparable to many surgical procedures, further strengthening our belief in the immense commercial opportunity of PRX302."

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