Prostate Cancer

Phase III clinical development of Acapodene on course following planned safety review

Published in Cancer Weekly, February 14th, 2006

GTx, Inc., (GTXI), a men's health biotech company, announced that a per protocol interim safety review by an independent Drug Safety Monitoring board (DSMB) recommended GTx continue clinical development as planned with its two pivotal phase III trials of Acapodene (toremifene citrate).

The DSMB meets regularly every 6 months to review unblinded safety data from the two pivotal phase III clinical trials. GTx is evaluating the use of Acapodene in an 80 mg dose for the treatment of multiple side effects of androgen-deprivation therapy (ADT) in men with advanced prostate cancer, and of Acapodene 20 mg dose for the prevention of prostate cancer in high risk men.

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Source: Cancer Weekly (2006-02-14)

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