Late stage development of PRX302 is supported by a successful randomized Phase IIb study with standard and well defined regulatory endpoints. PRX302 has shown meaningful improvements in the International Prostate Symptom Score (IPSS) and urinary flow rate (Qmax) at 3 and 6 months in this randomized, double-blind, placebo controlled Phase IIb trial (TRIUMPH). To date 126 patients with BPH have been treated with PRX302, demonstrating an attractive safety profile including no drug-related erectile dysfunction adverse events.
IPSS has been a primary endpoint and Qmax has been a secondary (or co-primary) endpoint for the FDA approval of currently available drugs for the treatment of BPH.
|Study||Phase (pts treated
|I / II (32 pts)||Randomized, Double-Blind, Placebo-Controlled, Transrectal route of injection|
|IIb (61 pts)||Randomized, Double-Blind, Placebo-Controlled, Transperineal route of injection|
|IIa (18 pts)||Open Label, safety, volume escalation, Transperineal route of injection|
|I (15 pts)||Open Label, safety, dose-escalation,
Transperineal route of injection