GTx has announced that an independent biometrics group recommended that 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.
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.
This update does not change GTx's assessment of the study's probability of success.
"The interim efficacy analysis was an opportunity for an early look in this landmark phase III PIN clinical trial," said Mitchell S. Steiner, MD, CEO of GTx. "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 20 mg compared to placebo reduces prostate cancer. 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 will make a final determination about the toremifene 20 mg phase III clinical trial after an efficacy analysis in the summer of 2009.
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 is developing toremifene citrate, a selective estrogen receptor modulator, or SERM, in two separate clinical programmes in men: first, 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, and second, 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.