Clinical Trial Research

GTx's Phase III Clinical Development of ACAPODENE on Course Following Planned Safety Review

Published in Medical Verdicts and Law Weekly, August 2nd, 2007

GTx, Inc. (Nasdaq: GTXI), today announced that a per protocol interim safety review by an independent Data Safety Monitoring Board (DSMB) recommended that GTx continue clinical development as planned with its two pivotal Phase III clinical trials of ACAPODENE(R) (toremifene citrate). The DSMB meets regularly every six months to review unblinded safety data from the two pivotal Phase III clinical trials.

"The DSMB reviewed safety data of the approximately 3,000 patients enrolled in the two pivotal Phase III ACAPODENE clinical trials and recommended that GTx continue with the trials as planned under the existing protocols," said Mitchell S. Steiner, MD, Chief Executive...

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Source: Medical Verdicts and Law Weekly (2007-08-02)

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