clinical studies

Clinical studies

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.

Clinical Trials
Study Phase (pts treated
with PRX302)
Design
PLUS 1
PRX302-3-01
enrollment completed
III (target 440 pts) Randomized, Double-Blind, Placebo-Controlled, Transrectal route of injection
PRX302-2-06
completed
I / II (32 pts) Randomized, Double-Blind, Placebo-Controlled, Transrectal route of injection
TRIUMPH PRX302-2-03
completed
IIb (61 pts) Randomized, Double-Blind, Placebo-Controlled, Transperineal route of injection
PRX302-2-02
completed
IIa (18 pts) Open Label, safety, volume escalation, Transperineal route of injection
PRX302-2-01
completed
I (15 pts) Open Label, safety, dose-escalation,
Transperineal route of injection
PLUS 1 phase III trial (PRX302-3-01)

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

A double-blind, multi-center, placebo controlled Phase IIa study in 40 patients with moderate to severe BPH. Patients were randomized to PRX302 or placebo within one of four dose cohorts in this transrectal study. The primary endpoint of the study was to evaluate the 3-month safety and tolerability of escalating doses of PRX302. The side effect profile in this Transrectal clinical trial was consistent with the side effects reported in the previous, transperineal PRX302 clinical trials, indicating that PRX302 injection by the Transrectal route was well tolerated, and was comparable to the transperineal route.

TRIUMPH phase IIb trial (PRX302-2-03)

A multi-center, double blinded, placebo controlled Phase IIb study (TRIUMPH) of PRX302 in men with moderate to severe BPH met its primary endpoint demonstrating a statistically significant improvement in IPSS from baseline when compared to placebo at 3 months post-treatment. In the study, patients treated with PRX302 showed an improvement of 9.1 points from baseline versus an improvement in IPSS of 5.8 points from baseline in patients receiving placebo (p<0.05) A clinically meaningful improvement was maintained throughout the 12 months (Elihilali, M. et al J Urol. 2013 Apr189 (4) : 1421-6).

PRX302-2-01 phase I and PRX302-2-02 phase II

The transperineal administration of PRX302 was well tolerated in these open label and dose-escalation and volume studies, and, IPSS scores improved significantly for up to 12 months after treatment. The dose escalation of 14-fold was well tolerated and the Maximum Tolerated Dose was not reached. No drug-related adverse events Grade 3 or higher were observed. Results supported further development of PRX302.