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Patient Enrollment Goal Achived in Phase 3 Trial of Toremifene, Treatment for Androgen Deprivation Therapy
"More than 1,300 patients in the United States 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 Mitchell Steiner, MD, 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 randomized, double blind, pivotal Phase III ADT study receive daily for two years either an 80 mg tablet of toremifene citrate or placebo. 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 (SPA) from the United States Food and Drug Administration.
Later in this quarter, GTx plans to conduct an interim analysis of bone mineral density in the first 200 patients to have completed a full year of treatment in this Phase III trial.
GTx is conducting under a separate SPA another pivotal Phase III trial of ACAPODENE in a 20 mg dose for the prevention of prostate cancer in high risk men who have high grade prostatic intraepithelial neoplasia, or high grade PIN. Under the PIN trial SPA, the timing for the interim efficacy analysis is driven by the rate of prostate cancer events among study patients. GTx expects the interim efficacy analysis will occur within 24 months after completing enrollment of the approximately 1,260 study subjects for the trial. If the interim efficacy analysis reveals a statistically significant reduction in prostate cancer, GTx expects to be able to file the New Drug Application (NDA). GTx will continue to collect efficacy and safety data during the NDA review process. Patient enrollment for the PIN trial began in the first quarter 2005 and is on track to be completed by the first quarter 2006.
Source: GTx, Inc.