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news.GTx has reported that toremifene citrate 80mg reduced hot flashes in men with prostate cancer on androgen deprivation therapy or ADT, a key secondary endpoint of the Phase III clinical trial evaluating toremifene citrate 80mg for the treatment of multiple side effects of ADT for advanced prostate cancer.
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In an analysis of hot flashes in a subset of patients in the Phase III ADT clinical trial experiencing six or more hot flashes per day at baseline and not being treated with megestrol acetate (Megace), toremifene citrate 80mg treatment reduced the number of hot flashes by an average of 4.7 hot flashes per day compared to placebo patients who had a reduction of 1.6 hot flashes per day (p=0.03). The reduction of hot flashes in patients treated with toremifene citrate 80mg was durable for at least 12 months. Toremifene citrate 80mg also had a favorable safety profile and was well tolerated.
Mitchell Steiner, CEO of GTx, said: “These hot flashes data provide additional confirmation that the multiple estrogen related side effects of androgen deprivation therapy for prostate cancer are treatable by toremifene citrate 80mg, which binds to and selectively modulates the estrogen receptor depending on tissue type.”