In late February 2008, GTx/NASDAQ: GTXI released top-line data from its ongoing pivotal Phase III trial evaluating Acapodene for the treatment of side-effects associated with prostate cancer. Once approved, sales could reach $600 million as Acapodene can improve bone mineral density and lower the lipid profile in prostate cancer patients.
Interim analysis of the Phase III trial evaluating Acapodene for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia is tentatively expected to occur in the first quarter of 2008. There is reason for optimism about Acapodene’s ability to prevent prostate cancer, given the intriguing Phase II results which demonstrated that participants treated for a full year with Acapodene had a 48% reduction in the incidence of prostate cancer versus placebo. Positive prostate prevention data could mean blockbuster status for GTx’s Acapodene. The company could file for regulatory approval in the U.S. and Europe (through partner Ipsen) later in 2008.
GTx’s shares went up on the good news, but it shares has drifted back down. We consider 2008 to be a pivotal year for GTx and a lot is riding on Acapodene.
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