GTx presents strong interim Ph II Acapodene data

Tennessee, USA-based biotechnology firm GTx says that Phase III interim data show that its oral, once-daily Acapodene (toremifene citrate) 80mg increases bone mineral density and lowers cholesterol in prostate cancer patients on androgen deprivation therapy. The two interim analyses, which were presented at the annual Prostate Cancer Symposium held by the American Society of Clinical Oncology, in Orlando, Florida, were conducted in the first 197 men who completed one year of treatment in GTx' pivotal Phase III clinical trial evaluating Acapodene for the treatment of multiple serious side effects of androgen deprivation therapy (ADT) for advanced prostate cancer.

ADT, the primary treatment for advanced prostate cancer, acts by reducing testosterone to castrate levels, effectively putting hormone-sensitive prostate cancer into remission. Because estrogen in men comes from testosterone, an unintended consequence of ADT is that it also reduces estrogen in men on ADT to levels well below even postmenopausal women. These low estrogen levels may result in multiple serious side effects, including osteoporosis, increased risk for life threatening fractures, adverse lipid changes, hot flashes and gynecomastia. GTx estimates that, by 2008, there will be one million prostate cancer patients on ADT in the USA alone.