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GTx, Inc. (GTXI) presented a safety analysis today demonstrating that fewer men treated with toremifene 80 mg had PSA progression over time compared to placebo in the Phase III clinical trial evaluating toremifene 80 mg for the treatment of multiple serious side effects of androgen deprivation therapy (ADT) for advanced prostate cancer. These data, as well as an additional analysis of bone turnover markers and fracture risk, were presented at the 2008 Annual Meeting of the American Society for Bone and Mineral Research in Montreal, Canada.
Among men in the intent-to-treat population with a detectable PSA (PSA a% 1 ng/ml) at baseline (n=419), significantly fewer men treated with toremifene 80 mg had PSA progression over time compared to men taking placebo (27% versus 37%, respectively; p < 0.05). This subgroup analysis is consistent with the recommendations of the Prostate Cancer Clinical Trials Working Group to measure prostate cancer progression in clinical studies. In another analysis among men with an undetectable PSA (PSA < 1 ng/ml) at baseline (n= 698), there was no difference in PSA progression in men treated with toremifene 80 mg compared to men taking placebo.
Toremifene 80 mg was well tolerated. Among the most common adverse events that occurred in over 2% of study subjects were joint pain (treated 7.3%, placebo 11.8%), dizziness (treated 6.3%, placebo 5.0%), back pain (treated 5.9%, placebo 5.2%), and extremity pain (treated 5.0%, placebo 4.4%). Venous thromboembolic events (VTE), which included both deep venous thrombosis and pulmonary embolism, were 2.4% in the toremifene 80 mg treated group and 1.02% in the placebo group. The majority of VTEs occurred in men at high risk for a VTE including: age greater than 80 years, history of VTE, recent surgical procedure and immobilization. Excluding high risk patients over the age of 80 years and with a history of VTEs, the VTEs were 1.3% in the toremifene 80 mg treated group and 1.0% in the placebo group (p=0.38). There was no difference in strokes, myocardial infarctions, or deaths between the two groups.
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