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news.GTx, a biotech company focusing on men's health, has initiated a phase IIIb extension trial to evaluate an 80mg dose of its drug candidate Acapodene for the treatment of serious side effects of androgen deprivation therapy in men with prostate cancer.
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Androgen deprivation therapy (ADT) lowers levels of male hormones and can cause prostate cancer tumors to shrink or grow more slowly, however the treatment is associated with several side effects including osteoporosis.
The purpose of this study is to collect additional efficacy and safety data that could further support the current phase III clinical study.
Prostate cancer patients in the company’s pivotal phase III trial of the drug who have completed the full two year treatment will be eligible to participate in the phase IIIb extension trial for an additional year.
The initiation of this phase IIIb study should not affect the current timeline for the completion of the ongoing phase III clinical trial in the second half of 2007 and the potential submission of the new drug application.
“This new clinical trial is a unique opportunity to continue to follow in a blinded fashion ADT patients completing our two year pivotal phase III study. It will allow us not only to obtain additional data regarding fractures and safety, but also to evaluate other possible benefits of Acapodene in this population,” said Dr Mitchell Steiner, CEO of GTx.