Protox completes enrollment of Phase 2b BPH trial
Protox Therapeutics Inc. announced that it has completed patient enrollment in its multi-centre, double-blinded, placebo controlled Phase 2b study of PRX302 (study name: TRIUMPH) in males with moderate to severe benign prostatic hyperplasia (BPH).
TRIUMPH is the third BPH clinical trial of PRX302 conducted by Protox. In addition to being well-tolerated, the previous open-label Phase 2 study reported at the 2009 Annual Meeting of the American Urological Association, showed an 11 point improvement in the International Prostate Symptom Score at the optimal PRX302 dose used in the TRIUMPH study.
In this multi-centre, double-blinded placebo controlled Phase 2b study, approximately 90 patients with moderate to severe BPH were randomized 2:1 (treatment : placebo). Each patient received PRX302 (3(micro)g/mL) or placebo at a volume equivalent to 20 percent of the total prostate volume. Dosing for each arm was delivered via a single ultrasound-guided injection into each lobe of the prostate. The primary objective of this study is to evaluate the efficacy of PRX302 compared to placebo as measured by the changes in IPSS (International Prostate Symptom Score) in subjects with moderate to severe BPH at 90 days post-treatment. In addition, the study will also compare efficacy of PRX302 with respect to changes from baseline in Quality of Life scores (QoL), urodynamic parameters (Qmax, PVR), proportion of responders and prostate size.
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