Topsalysin: Interim Phase III data

An interim analysis by the IDMC of the double-blind, vehicle-controlled, international Phase III PLUS-1 in 479 patients with BPH showed that a single intraprostatic injection of 0.6 µg/g PRX302 did not meet the pre-defined efficacy threshold of improving IPSS from baseline to week 12. Sophiris, which remains blinded to the data, said the analysis was conducted specifically for planning subsequent trials and will not affect PLUS-1. Patients will continue to be followed for the duration of the trial to evaluate the primary endpoint of the change from baseline in IPSS total score at week 52. ...