It's not necessary to be the flashy Dendreons
After androgen-deprivation therapy with drugs such as AstraZeneca's
Toremifene achieved its primary goal by reducing bone fractures in patients' backs by 50%. GTx said the drug was also better than the placebo in all the other objectives except the one that patients probably find most annoying -- hot flashes. GTx is still evaluating the hot flash data, which won't be presented until the full data set is made public at a medical meeting.
The only safety concern in the trial was an elevated incidence of blood clots, which GTx could address with a warning label that says that patients at high risk of getting blood clots shouldn't take the drug.
Toremifene is in the same class of drugs as breast cancer treatment tamoxifen and Eli Lilly's
GTx plans to file a New Drug Application with the Food and Drug Administration by the summer. Because there are no approved drugs to treat the side effects of androgen-deprivation therapy, the company probably will get a six-month priority review and have an answer back from the FDA before the end of the year.
The unpopular drugmaker -- it has only 67 Motley Fool CAPS ratings -- is trying to get a little more attention. Next month, it plans to release results from another phase 3 trial testing toremifene to prevent prostate cancer in men with a premalignant lesion called prostatic intraepithelial neoplasia (PIN). If those results are as good as the ones released yesterday, more investors should take note of GTx.