PRX 302 Phase III efficacy threshold for BPH is not met- Sophiris Bio
Sophiris Bio Inc.developing PRX 302 (topsalysin) for the treatment of symptoms of Benign Prostatic Hyperplasia (BPH, enlarged prostate) and the treatment of localized Prostate Cancer, announced findings from an administrative interim analysis of efficacy in its ongoing Phase III "PLUS-1" trial of PRX 302 as a treatment for lower urinary tract symptoms of BPH.
The Independent Data Monitoring Committee (IDMC) reported that a predefined efficacy threshold following treatment was not achieved. This administrative interim analysis was conducted specifically for planning subsequent clinical trials. The ongoing "PLUS-1" study is unaffected by this recommendation, and all patients in the study will continue to be followed to enable the evaluation of the primary efficacy endpoint at 52 weeks.
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