GTx prostate-cancer drug reduces hot flashes in men


Biotechnology company GTx Inc said a late-stage trial showed its experimental drug, toremifene citrate, reduced hot flashes in men who were on Androgen deprivation therapy (ADT), a common treatment for advanced prostate cancer.
Reducing hot flashes was a secondary goal for the 80 milligram dose of the drug in the trial, which studied 1,389 patients over a period of two years.
In late February, the company said a late-stage trial showed the drug reduced spinal fractures and other side effects caused by ADT, a hormone therapy which works by reducing testosterone and estrogen.
"Hot flashes are the most common and bothersome symptomatic side effect of ADT. Up to 80 percent of men on ADT report being troubled by hot flashes, which are often cited as a cause of noncompliance with hormone therapy," Matthew Smith, the lead investigator of the trial, said in a statement.
GTx plans to seek U.S. approval for toremifene, licensed from Finland's Orion Corp, by this summer and expects a priority review, putting it on track for approval by the end of this year or early 2009.