GTx: Acapodene reduces side effects of androgen deprivation therapy in prostate cancer

By Lisa Kerner

Charlotte, N.C., June 22 - GTx, Inc. said prostate cancer patients on androgen deprivation therapy who received Acapodene had better cholesterol levels compared to a placebo.

The study found they had lower total cholesterol (-7.1%), LDL (-9.0%) and triglyceride (-20.1%) levels, a reduction in the total cholesterol/HDL ratio (-11.7%) and higher HDL levels (+5.4%).

The lipid interim analysis was performed in the first 197 subjects who completed one year of a pivotal phase 3 clinical trial evaluating oral, once daily Acapodene (toremifene citrate) 80mg for the treatment of the multiple serious side effects of androgen deprivation therapy in men with advanced prostate cancer.

"Androgen deprivation therapy is quite effective in turning prostate cancer into a chronic disease in many patients," lead principal investigator Matthew R. Smith said in a company news release.

"As patients are living longer with prostate cancer because of ADT [androgen deprivation therapy], serious side effects have become major causes of morbidity and even death. These serious ADT side effects include osteoporosis and fractures as well as adverse lipid changes and cardiovascular disease."

A total of 1,400 men are taking part in the study at more than 150 sites in the United States and Mexico. The primary endpoint of the trial is a reduction in vertebral fractures, with secondary endpoints including improvements in bone mineral density, hot flashes, gynecomastia and lipid profiles.

GTx said it expects final data from the trial in the second half of 2007.

Located in Memphis, Tenn., GTx is a biopharmaceutical company focused on cancer and men's health.

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