GTx Announces Phase III PIN Clinical Trial Will Continue As Planned
Friday May 23, 6:00 am ET
MEMPHIS, Tenn.--(BUSINESS WIRE)--GTx, Inc. (Nasdaq: GTXI - News) today 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.
About the study
The three year, double blind, placebo controlled Phase III PIN clinical trial randomized 1,590 men with high grade PIN at 150 clinical sites in the United States and Canada. The primary endpoint of the event driven study is prostate cancer incidence.
-----------------------
I at one point actually thought the the final data was due now because of the way they wrote some of their slides. I guess they really thought that they would hit p<.001 on the interim. |
