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GTx's (GTXI) Enobosarm Positive in Phase II, Shares Down

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GTx, Inc. announced positive top-line data from a phase II study, evaluating lead pipeline candidate, enobosarm 3 mg (GTx-024), for treating postmenopausal women with stress urinary incontinence (SUI). Data from the study was presented at International Continence Society (ICS) Annual Meeting.

Shares of GTx have decreased almost 9% despite the good news as the data announced was probably below market expectations. However, shares of the company have outperformed the industry so far this year. The stock has surged 42.4% compared with the broader industry's increase of 16%.

The open-label, non-placebo controlled, proof-of-concept phase II study was conducted on 17 postmenopausal women with SUI. The trial met primary endpoints and revealed that women treated with enobosarm experienced significant reduction (50% or greater) in incontinence episodes per day compared with baseline, which sustained for up to seven months following completion of treatment. Mean stress leaks declined by 83% from baseline over a period of 12 weeks. Adverse events reported in the study were minimal.

Based on results from the study, GTx started a randomized, placebo-controlled phase II clinical trial to evaluate the safety and efficacy of enobosarm across two doses (1 mg and 3 mg) compared with placebo in postmenopausal women with SUI.

Investors are reminded that presently, the company is conducting another phase II study, evaluating enobosarm in patients whose advanced breast cancer is both estrogen receptor (ER) positive and androgen receptor (AR) positive. Top-line data from the program is expected later in 2017.

Notably, enobosarm has already been assessed in 24 completed or ongoing clinical trials for SUI enrolling over 1,700 subjects, of which, approximately 1,200 were treated with enobosarm at doses, ranging from 0.1-100 mg.

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