GTx Continues Trials of Prostate Cancer Drug Candidate After OK by Safety Monitoring Board

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GTx Continues Trials of Prostate Cancer Drug Candidate After OK by

Safety Monitoring Board

September 5, 2006 - 11:12 a.m.

MEMPHIS, Tenn. (AP) - Biopharmaceutical company GTx Inc. said Tuesday it

will continue two late-stage studies of its prostate cancer drug

candidate after an independent drug safety monitoring board recommended

GTx continue the research.

The monitoring board had reviewed the safety data of more than 2,700

patients enrolled in two Phase III clinical trials for Acapodene.

The primary endpoint of the first, 1,400-patient study is the reduction

of bone fractures in men with prostate cancer. The study is evaluating

Acapodene's ability to treat multiple side effects of androgen

deprivation therapy for prostate cancer, which include lower bone

mineral density, hot flashes, and gynecomastia, or the development of

abnormal breast tissue on men.

snip

The second trial, which comprises 1,340 patients, aims at preventing

prostate cancer in men with high grade prostatic intraepithelial

neoplasia, which doctors believe is a precursor to prostate cancer. The

condition involves changes in the appearance of prostate gland cells.

The primary endpoint of the trial is a reduction in prostate cancer

incidence.

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Kathy Meade