Dallas, Texas 12/16/2014 (FINANCIALSTRENDS) – Sophiris Bio Inc (NASDAQ:SPHS) announced Phase III PLUS-1 trial results for its PRX302 candidate, which indicated for the treatment of lower urinary tract symptoms of Benign Prostatic Hyperplasia (BPH). The Independent Data Monitoring Committee concluded that a pre-defined efficacy threshold was not achieved following the treatment with PRX302. This interim analysis was conducted to guide subsequent clinical trials.
However, the company noted that the findings of this interim analysis won’t affect the ongoing PLUS-1 study. Sophiris will continue to follow all patients enrolled in this study to further assess the primary efficacy endpoint at 52 weeks.
Investors reacted heavily to this discouraging finding with more than 7.4 million shares changing hands compared to its average volume of 52,773 shares. The stock fell 81.3% to $0.52 a share.
PLUS-1 Clinical Trial
Sophiris Bio Inc (NASDAQ:SPHS)’s PLUS-1 study is a multicenter, double-blind, randomized clinical trial aimed at assessing the efficacy and safety profile of a single administration of PRX302 for BPH. The primary endpoint for this study is the change in IPSS (International Prostate Symptom Score) total score from baseline at 52 weeks. Secondary endpoint includes change in Qmax from baseline at 52 weeks. The company announced to complete enrollment and dosing for all 479 patients for this study in September 2014.
Continuing the PLUS-1 Study
The committee completed the planned administrative analysis of efficacy based on the change in IPSS score from baseline to Week 12 for all patients dosed in the study. It conveyed its recommendation to the company and others directly involved in the study in a manner that they would remain blinded to the study.
Randall Woods, President and CEO of Sophiris Bio Inc (NASDAQ:SPHS), said that the study will continue to enable us evaluate the primary endpoint at 52 weeks. The company would provide further updates in 2H15, once the study is complete and all the data through 52 weeks are analyzed.