In order to preserve the integrity of the clinical trial and allow the study to continue without introducing bias, GTx did not receive data from the interim efficacy analysis. GTx will make a final determination about the toremifene 20mg Phase III clinical trial after an efficacy analysis in the summer of 2009.
The three year, double blind, placebo controlled Phase III prostatic intraepithelial neoplasia (PIN) clinical trial randomized 1,590 men with high grade PIN at 150 clinical sites in the US and Canada. The primary endpoint of the event driven study is prostate cancer incidence.
Mitchell Steiner, CEO of GTx, said: “Based on the strong supportive science and the fact that time is an important factor in cancer prevention studies, we are confident that the Phase III PIN clinical trial will demonstrate that toremifene 20mg compared to placebo reduces prostate cancer.”