GTx: Analysis shows Acapodene raises bone mineral density in men with prostate cancer

By E. Janene Geiss

Philadelphia, Dec. 15 - GTx, Inc. reported Thursday that men with prostate cancer on androgen-deprivation therapy experienced highly statistically significant increases in bone mineral density after one year of treatment with Acapodene (toremifene citrate) 80 mg dose.

Patients treated with Acapodene demonstrated statistically significant increases in bone mineral density versus patients receiving placebo for each of the three different skeletal sites measured. In lumbar spine, bone mineral density increased +2.3%, in hip, +2%, and in femoral neck, +1.5%, versus placebo, according to a company news release.

The planned interim analysis of bone mineral density, a secondary endpoint of the trial, was conducted in accordance with a Special Protocol Assessment with the Food and Drug Administration for the company's pivotal phase 3 trial for the use of Acapodene, a selective estrogen receptor modulator, or SERM, to treat the multiple serious side effects of androgen-deprivation therapy.

The analysis examined bone mineral density in the first 200 patients to complete one 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, officials said.

This interim analysis is the largest prospective study reported to date of osteoporosis and bone loss in men with hormone sensitive prostate cancer on androgen-deprivation therapy, officials said.

"Acapodene's bone mineral density changes are of a magnitude that should deliver the desired fracture benefit, as they are consistent with bone mineral density 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 androgen-deprivation therapy," said Matthew Smith, associate professor of medicine at Harvard Medical School and lead trial investigator, in the release.

Patients in the double-blind, pivotal phase 3 androgen-deprivation therapy 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, officials said.

The trial has 1,394 subjects enrolled at 150 clinical sites in the United States and Mexico. The target enrollment was achieved in the third quarter of 2005, officials said.

GTx is a Memphis, Tenn., biopharmaceutical company dedicated to development and commercialization of therapeutics for cancer and serious conditions related to men's health.

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