GTx to continue with the phase III clinical trial evaluating toremifene 20 mg in men with high grade prostatic intraepithelial neoplasia, or PIN, who are at increased risk for prostate cancer should continue as planned following an interim efficacy analysis
GTx, Inc, is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways to treat cancer, osteoporosis and bone loss, muscle wasting and other serious medical conditions. GTx will make a final determination about the toremifene 20 mg phase III clinical trial after an efficacy analysis in the summer of 2009.Additionally, the prespecified level of statistical significance required in the final efficacy decision is a lower statistical hurdle than was required in the interim analysis".
GTx is developing toremifene citrate, a selective estrogen receptor modulator, or SERM, in two separate clinical programmes in men. Firstly, a completed pivotal phase III clinical trial evaluating toremifene citrate 80 mg for the treatment of serious side effects of androgen deprivation therapy for advanced prostate cancer.
Secondly, an ongoing pivotal phase III clinical trial evaluating toremifene citrate 20 mg for the prevention of prostate cancer in high-risk men with high grade prostatic intraepithelial neoplasia, or PIN.