GTx study continues after safety review

Biopharmaceutical company GTx Inc. said Monday it is continuing a late-stage study of its experimental prostate cancer drug after completing a planned safety review.

The company said it will continue the Phase III clinical trial of toremifene in 20-milligram doses to prevent prostate cancer in men with a type of tissue lesion called prostatic intraepithelial neoplasia. The lesions are considered precursors to prostate cancer.

GTx expects a full analysis of the program in the summer of 2009. The company's independent data safety monitoring board meets every six months to review unblinded safety data on toremifene, which is being developed under a special program with the Food and Drug Administration.

Toremifene is also being developed in an 80-milligram dose to reduce side effects of a prostate cancer treatment called androgen deprivation therapy, which are hormone injections that work by lowering testosterone and estrogen.

Those side effects can include bone loss and fractures, hot flashes, cholesterol changes and increased heart-attack risk.

Shares of GTx closed at $18.69 Friday.