The Data Safety Monitoring Board (DSMB) meets every six months to review unblinded safety data from the toremifene Phase III clinical trials.
Nearly 1,600 patients with high grade prostatic intraepithelial neoplasia have been enrolled in the toremifene 20mg Phase III high grade prostatic intraepithelial neoplasia clinical trial. The primary endpoint of the trial is a reduction in prostate cancer incidence.
The trial is being conducted under a special protocol assessment with the FDA. GTx anticipates conducting an efficacy analysis of toremifene 20mg in the summer of 2009.
Mitchell Steiner, CEO of GTx, said: “The DSMB has reviewed safety data of the nearly 3,000 men enrolled in the toremifene 80mg and toremifene 20mg Phase III clinical trials. The accumulated safety data extend as long as two years for toremifene 80mg and three years for toremifene 20mg.”