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Positive Interim Results Reported for Phase 3 Trial of Toremifene
Patients treated with ACAPODENE demonstrated statistically significant increases in BMD versus patients receiving placebo for each of the three different skeletal sites measured. In lumbar spine, BMD increased +2.3% (p The planned interim analysis of BMD, a secondary endpoint of the trial, was conducted in accordance with a Special Protocol Assessment with the FDA for the company's pivotal Phase III trial for the use of ACAPODENE, a selective estrogen receptor modulator, or SERM, to treat the multiple serious side effects of ADT. The analysis examined BMD in the first 200 patients to complete one full year of treatment in order to give confidence that ACAPODENE would deliver at two years the trial's primary endpoint, a 40% reduction in fractures. This interim analysis is the largest prospective study reported to date of osteoporosis and bone loss in men with hormone sensitive prostate cancer on ADT.
Matthew Smith, MD, PhD, an Associate Professor of Medicine at Harvard Medical School, said "ACAPODENE's BMD changes are of a magnitude that should deliver the desired fracture benefit, as they are consistent with BMD changes that have translated into greater than 50% fracture reductions in other SERM trials of post-menopausal women. I believe ACAPODENE will fill an important unmet medical need, as there are no other FDA approved treatments available to reduce fractures in men with hormone sensitive prostate cancer on ADT." Dr. Smith is a lead physician investigator for GTx's ADT Phase III trial.
Mitchell Steiner, MD, CEO of GTx, said "Based on our Phase II data and the supporting scientific literature, we expected ACAPODENE to build bone in men on ADT. These results have confirmed the significant bone activity of ACAPODENE and offer hope that ACAPODENE will reduce life threatening fractures in the approximately 1 million men on ADT in the US. We also remain confident that our Phase III trial of ACAPODENE will show benefits in the trial's other secondary endpoints, including improvements in the lipid profile of the men receiving ACAPODENE, as cardiovascular disease is a leading cause of death for men on ADT."
Patients in the double blind, pivotal Phase III ADT trial are randomized to receive daily either an 80 mg dose of toremifene citrate or matching placebo for 24 months. The primary endpoint of the trial is the occurrence of radiographic vertebral fractures. Secondary endpoints include reduction of hot flashes and improvement in gynecomastia, lipid profiles, bone mineral density, and quality of life. 1,394 subjects are currently enrolled at 150 clinical sites in the United States and Mexico. GTx reached its enrollment goal in the third quarter of 2005.
Source: GTx, Inc.