GTx is evaluating the use of Acapodene (toremifene citrate) in an 80mg dose for the treatment of multiple side effects of androgen deprivation therapy (ADT) in men with advanced prostate cancer, and of Acapodene 20mg dose for the prevention of prostate cancer in high risk men. The drug safety monitoring board (DSMB) meets every six months to review unblinded safety data from the two pivotal phase III clinical trials.
In the first study, 1,388 prostate cancer patients on ADT at approximately 150 clinical centers in the US and Mexico were randomized to receive an oral daily 80mg dose of Acapodene or placebo. The primary endpoint of the trial is a reduction in vertebral fractures. Secondary endpoints include improvements in bone mineral density, lipid profile, gynecomastia, and hot flashes.
In the second study, Acapodene 20mg is being evaluated for the prevention of prostate cancer in men with the premalignant lesion called high grade prostatic intraepithelial neoplasia (PIN). In this trial, 1,260 men are being randomized at more than 130 sites in the US, Canada, Mexico and Argentina to receive an oral daily 20mg dose of Acapodene or placebo. The primary endpoint of the trial is the reduction of prostate cancer incidence. Enrollment of the trial is expected to be completed in the first quarter of 2006.
“The DSMB reviewed safety data of more than 2,000 patients enrolled in our two phase III trials and recommended that GTx continue with the trials as planned. This welcome news, along with the efficacy demonstrated recently in the interim analysis of BMD in our ADT trial, reduces the risk in Acapodene’s clinical development and improves the prospects that we will be able to submit these product candidates for marketing approval,” said Dr Mitchell Steiner, CEO of GTx.