Sophiris Bio Inc. (SPHS) Reports Completion Of Enrollment In The "PLUS-1" Phase 3 Trial Of PRX302 For Benign Prostatic Hyperplasia
9/2/2014 11:04:46 AM
SAN DIEGO & VANCOUVER, British Columbia--(BUSINESS WIRE)--Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of the symptoms of benign prostatic hyperplasia (BPH, enlarged prostate) and for the treatment of localized prostate cancer, today announced that it has fully enrolled its ongoing Phase 3 trial (referred to as PLUS-1) of PRX302 as a treatment for lower urinary tract symptoms of BPH.
The PLUS-1 trial is an international, multi-center, randomized, double-blind and vehicle-controlled Phase 3 study that will assess the safety and efficacy of a single intraprostatic administration of PRX302 (0.6 µg/g prostate) for the treatment of BPH. The primary endpoint is the International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks. Secondary endpoints include Qmax (maximum urine flow) change from baseline over 52 weeks.
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