“More than 1,300 patients in the US and Mexico are now participating in our phase III ADT trial. We are on track to have final data from this trial in the second half of 2007,” said Dr Mitchell Steiner, CEO of GTx. “Men on ADT are at high risk for developing osteoporosis and life threatening fractures. Studies have shown that average survival is reduced by 39 months in ADT patients who do develop fractures.”
Patients in the pivotal phase III ADT study will receive either an 80 mg tablet of Acapodene or placebo every day for two years. The primary endpoint of the trial is the occurrence of lumbar vertebral fractures. Secondary endpoints include hot flashes, gynecomastia, improvement in lipid profiles, and bone mineral density.
GTx is conducting this two year study in accordance with a special protocol assessment from the FDA.