GTx Inc. (GTXI), which is awaiting FDA approval for toremifene 80 mg, an investigational drug for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy, will host a conference call and webcast on Monday, November 2, to provide an update on the drug's status. The FDA was to make a decision on the drug on October 30.
Androgen deprivation therapy, or ADT, the main treatment for advanced prostate cancer, works by reducing testosterone levels by up to 95%. Testosterone is a primary growth factor of prostate cancer. However ADT also substantially depletes estrogen levels, the hormone responsible for bone quality and strength.
Depletion of estrogen can result in serious side effects, including a high risk of bone fractures, adverse lipid changes and increased risk of cardiovascular disease, as well as common symptomatic side effects such as growth of breast tissue often accompanied by tenderness and pain, and hot flashes.
GTx already markets toremifene 60 mg under the brand name Fareston for the treatment of advanced breast cancer in more than 60 countries including the U.S.
The company is also conducting a pivotal phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in men with precancerous lesion called high grade prostatic intraepithelial neoplasia, or PIN. The primary endpoint of the study is a reduction in the incidence of prostate cancer. GTx plans to conduct the final analyses of the clinical trial following the conclusion of the study in the first-quarter of 2010.
GTXI lost over 10% Friday to close at $8.98. In after-hours trading, the shares further slipped more than 8% to $8.25.
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