=GTx (GTXI) : positive trial results

GTx Announces Positive Preliminary Results from Ongoing Phase 2 Proof-of-Concept Clinical Trial in Women with Stress Urinary Incontinence

GTx, Inc. (GTXI) today announced release of preliminary clinical data from its ongoing, open-label, Phase 2 clinical trial of enobosarm 3 mg (GTx-024) in postmenopausal women with stress urinary incontinence (SUI). An abstract entitled “Kegels In A Bottle”: Preliminary Results Of A Selective Androgen Receptor Modulator (GTx-024) For The Treatment Of SUI In Post-Menopausal Women, summarizing clinical data from the first seven patients completing 12 weeks of treatment with enobosarm, is now available on the International Continence Society’s website. This proof-of-concept clinical trial is the first of its kind to evaluate an orally-administered selective androgen receptor modulator (SARM) for SUI.

In this ongoing Phase 2 clinical trial, enobosarm 3 mg is being given to post-menopausal women who have demonstrated SUI symptoms for more than six months, with 3 to 15 reported SUI episodes per day averaged over a three-day period, and a positive bladder stress test. The primary endpoint is the number of SUI episodes per day on the 3-day voiding diary at 12 weeks, compared to base line. The clinical findings from the first seven patients enrolled in the study following their completion of treatment, as outlined in the abstract, are summarized below.

• Each of the women treated with enobosarm showed a clinically significant reduction in incontinence episodes per day:
  • Mean stress leaks decreased by 80.9 percent from baseline over 12 weeks
  • Stress leaks decreased from a mean of 5.7 leaks/day at baseline, to 1.1 leaks/day at Week 12
  • All patients saw at least a 65 percent reduction in number of stress leaks
• Reductions in incontinence episodes were sustained well beyond the stopping of study drug at Week 12:
  • Patients demonstrated continued reduction in incontinence episodes for up to five months
• Women reported improved quality of life in the Patient Global Impression of Improvement (PGI-I) and Female Sexual Function Index (FSFI)
  • At Week 12, all seven patients showed improved PGI-I scores and 5 of 7 patients showed improvement in FSFI
• Reported adverse events are minimal with none above Grade I

“With approximately half the women in the United States experiencing symptoms of SUI, there is a growing need for an effective oral therapy to treat women with stress urinary incontinence,” said Kenneth M. Peters, M.D., Professor and Chairman of Urology, Oakland University William Beaumont School of Medicine. “I am very encouraged by the consistency and strength of these early results, and I look forward to presenting more detailed clinical data from this ongoing clinical trial at the upcoming International Continence Society (ICS) meeting.”