FDAnews
www.fdanews.com/articles/107081-gtx-prostate-cancer-trial-will-continue-as-planned

GTx Prostate Cancer Trial Will Continue as Planned

May 27, 2008

An independent biometrics group has recommended that GTx continue its Phase III prostate cancer trial as planned following an interim efficacy analysis.

The three-year, double-blind, placebo-controlled trial in 1,590 randomized men is evaluating toremifene 20 mg in patients with high-grade prostatic intraepithelial neoplasia, who are at increased risk for prostate cancer.

To preserve the integrity of the trial and allow the study to continue without introducing bias, GTx has not received data from the interim efficacy analysis.

The company said it will make a final determination about the trial after the efficacy analysis next year.