GTx announced today the initiation of a pivotal Phase III clinical trial of Acapodene (Toremifene Citrate) tablets to reduce the incidence of skeletal fractures and other serious complications of androgen deprivation therapy in men who have advanced prostate cancer. We expect to enroll 1,200 patients in this 24 month, placebo controlled pivotal study in the United States.

The standard medical treatment for the more than 675,000 men in the United States with advanced prostate cancer is androgen deprivation therapy. Androgen deprivation is accomplished either surgically by removal of the testes or chemically by treatment with LHRH agonists such as Lupron and Zoladex. Side effects associated with LHRH agonists include bone loss leading to osteoporosis and skeletal fractures, hot flashes and gynecomastia. We believe that Acapodene may potentially treat these serious side effects of LHRH agonists.

Acapodene is a nonsteroidal SERM, a small molecule that binds and selectively modulates the estrogen receptor. SERMs have been shown to stimulate estrogen receptors in bone and block estrogen receptors in the breast. SERMs may also potentially block estrogen receptors in the prostate. GTx is evaluating Acapodene for the treatment of certain side effects of androgen deprivation such as osteoporosis and skeletal fractures, hot flashes and gynecomastia in men who have advanced prostate cancer.

GTx has licensed the right to develop, market and distribute toremifene, the active ingredient of Acapodene tablets, worldwide in the field of the prevention and treatment of prostate cancer and the prevention and treatment of osteoporosis, hot flashes and gynecomastia as side effects of androgen deprivation therapy for prostate cancer from Orion Corporation, Finland.

GTx is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics primarily related to the treatment of serious men's health conditions and diseases. GTx's drug discovery and development programs are focused on small molecules that selectively modulate the effects of estrogens and androgens.