Sophiris Bio Inc. Announces First Patients Dosed in the "PLUS-1" Phase 3 Trial of PRX302 for Benign Prostatic Hyperplasia
Published: Oct 29, 2013
SAN DIEGO & VANCOUVER, British Columbia--(BUSINESS WIRE)--Sophiris Bio Inc. (NASDAQ: SPHS) (TSX: SHS) today announced that enrollment has begun and the first patients have been dosed in a Phase 3 trial of PRX302 (topsalysin) as a treatment for lower urinary tract symptoms of benign prostatic hyperplasia (BPH or enlarged prostate). The Phase 3 international, multi-center study, called the PLUS-1 study, will enroll approximately 440 patients. The randomized, double-blind and vehicle-controlled study will assess the safety and efficacy of a single intraprostatic injection 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 change from baseline (maximum urine flow) over 52 weeks.
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