Protox Reports Positive Results From Phase 2b Trial Evaluating PRX302

The study has achieved its primary clinical endpoint of a statistically improvement in International Prostate Symptom Score (IPSS) for patients treated with PRX302 versus subjects receiving placebo.

In the study, of the 73 per protocol efficacy evaluable subjects, 52 has received PRX302 and 21 received placebo. The PRX302 arm showed an average IPSS improvement at 90 days of 9.1 points versus an average IPSS improvement of 5.8 points for the placebo arm, a statistically positive improvement of 3.3 points. Baseline average IPSS for the PRX302 and placebo groups were 23.5 and 22.9 points, respectively.

The company said that a sub-group analysis was performed for subjects with severe BPH. Results of this sub-group analysis showed that those treated with PRX302 had an average IPSS improvement at 90 days from baseline of 10.8 versus an improvement of 5.8 for those receiving placebo for an overall 5.0 point improvement over placebo.

Fahar Merchant, president and CEO of Protox, said: “We are very excited about the results of the Triumph study. We believe that PRX302 has an immense commercial opportunity and look forward to sharing these impressive data with our potential partners.”

Mostafa Elhilali, chief co-principal investigator and Stephen Jarislowsky chair of urology at McGill University, said: “The future for new drug development is to create molecules that target the organ or cell of interest and affect it as needed with minimal collateral damage. PRX302 is an excellent example of such a designer drug that targets cells producing PSA which is limited to the prostate gland.

“The study results from this placebo controlled trial showed that injecting PRX302 in the prostate produced the desired effects with minimal side effects which is quite exciting. Furthermore, improvements in symptoms were also associated with improvements in flow rates and Quality of Life measures.”