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). Prior to Phase III, 126 patients with BPH had been treated with PRX302, demonstrating an attractive safety profile including no drug-related erectile dysfunction adverse events. Enrollment into a Phase III clinical trial (PLUS 1) has been completed.
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
|III (target 440 pts)||Randomized, Double-Blind, Placebo-Controlled, Transrectal route of injection|
|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
A double-blind, multi-national, placebo controlled Phase III study enrolled 440 patients with moderate to severe BPH. Patients were randomized to PRX302 or placebo in this pivotal study. The primary endpoint of the study is to evaluate the 12-month safety and efficacy of PRX302. This study includes a blinded administrative analysis which is expected to be completed around the end of 2014 followed by a complete 12 month data analysis in the second half of 2015. For more information please see study NCT1966614 on www.clinicaltrials.gov. For patients interested in participating in the trial please call 855-72-MYBPH (855-726-9274).PRX302-2-06 phase I/II trial TRIUMPH phase IIb trial (PRX302-2-03) PRX302-2-01 phase I and PRX302-2-02 phase II