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|GTx Announces Positive Results from Enobosarm Phase 2 Proof-of-Concept Clinical Trial in Women with Stress Urinary Incontinence|
-- Data presented at the International Continence Society Annual Meeting today demonstrated:
* Clinically significant reductions in incontinence episodes per day in all patients completing 12 week treatment
* Reductions in incontinence episodes were sustained for up to 7 months following completion of enobosarm treatment
-- Placebo-controlled Phase 2 clinical trial designed to further
evaluate enobosarm in postmenopausal women with SUI initiated in
“All 17 patients completing treatment have shown a significant reduction
in the number of leaks per day recorded at their baseline, and the
improvements in symptoms were sustained well beyond ceasing enobosarm
treatment at 12 weeks,” said
The podium presentation entitled “Kegels In A Bottle”: Preliminary Results Of A Selective Androgen Receptor Modulator (GTx-024) For The Treatment Of SUI In Post-Menopausal Women, summarized clinical data from the first 17 patients completing 12 weeks of enobosarm treatment, including the duration of response for up to 7 months following completion of enobosarm treatment. In this trial, a total of 19 post-menopausal women were enrolled by three clinical sites to receive enobosarm treatment. In addition to the 17 patients who completed treatment, another will complete treatment in approximately 8 weeks and one patient previously withdrew consent shortly after her initial visit. Data highlights were as follows:
Each of the women treated with enobosarm showed a clinically significant reduction in incontinence episodes per day:
Reductions in incontinence episodes were sustained well beyond the 12 week treatment period:
Women reported improved quality of life measurements in each of the five instruments collected in the study, including the Patient Global Impression of Improvement (PGI-I) and Female Sexual Function Index (FSFI):
There were no serious adverse events reported and reported adverse events were minimal and included headaches, nausea, fatigue, hot flashes, insomnia, muscle weakness and acne. Mild transient elevations in liver enzymes were observed, as well as reductions in total cholesterol, LDL, HDL and triglycerides. The presentation can be found on the Company’s website. The abstract is available on the International Continence Society’s website.
Based on the results from its enobosarm Phase 2 proof-of-concept study, the Company has initiated a randomized, placebo-controlled Phase 2 clinical trial to evaluate the change in frequency of daily stress urinary incontinence episodes following 12 weeks of treatment. The trial will evaluate the safety and efficacy of enobosarm (1 mg and 3 mg) compared with placebo in postmenopausal women with SUI. Enobosarm has previously been evaluated in clinical trials enrolling in excess of 1,700 patients, in which approximately 1,200 individuals received doses ranging from 0.1 mg to 100 mg, and has been observed to be generally safe and well tolerated.
“Since stress incontinence occurs when muscles that control one’s
ability to hold urine get weak or do not work, it stands to reason that
increasing pelvic floor muscle mass should reduce involuntary or
unintentional leakage of urine,” said Dr.
About the Phase 2 Proof-of-Concept Clinical Trial
The single-arm, open-label Phase 2 clinical trial is evaluating enobosarm in postmenopausal women with SUI, and is the first clinical trial to evaluate an orally administered selective androgen receptor modulator (SARM) for SUI. More information about the clinical trial can be found here.
About Stress Urinary Incontinence
Stress urinary incontinence (SUI) refers to the unintentional leakage of urine during activities that increase abdominal pressure such as coughing, sneezing or physical exercise. SUI, the most common type of incontinence suffered by women, affects up to 35 percent of adult women. There are a variety of treatments that are used to treat SUI in women, such as behavioral modification and pelvic floor physical therapy, especially as initial treatment options. As the condition worsens, however, bulking agents and surgical procedures are often the most widely used treatments.
About Enobosarm and SUI
Enobosarm, a selective androgen receptor modulator (SARM), has been evaluated in 24 completed or ongoing clinical trials enrolling over 1,700 subjects, in which approximately 1,200 subjects were treated with enobosarm at doses ranging from 0.1 mg to 100 mg. At all evaluated dose levels, enobosarm was observed to be generally safe and well tolerated. The rationale for evaluating enobosarm as a treatment for SUI is supported by preclinical in vivo data demonstrating increases in pelvic floor muscle mass following treatment with GTx’s SARM compounds, including enobosarm, and the ongoing proof-of-concept Phase 2 clinical trial of enobosarm 3 mg for the treatment of postmenopausal women with SUI.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon
GTx's current expectations. Forward-looking statements involve risks and
uncertainties, and include, but are not limited to, statements relating
to GTx's ongoing clinical trials of, and the therapeutic potential of,
enobosarm (GTx-024) to treat stress urinary incontinence (SUI). GTx's
actual results and the timing of events could differ materially from
those anticipated in such forward-looking statements as a result of
these risks and uncertainties, which include, without limitation, the
risks (i) that clinical trials being conducted by GTx may not be
completed on schedule, or at all, or may otherwise be suspended or
terminated; (ii) that the development of enobosarm to treat SUI is at an
early stage, is subject to the substantial risk of failure inherent in
the development of early-stage product candidates, and will require
significant additional financial resources in order for such development
to continue; (iii) that any additional clinical development of enobosarm
to treat SUI is contingent on GTx entering into new collaborative
arrangements with third parties for such development or otherwise
obtaining sufficient additional capital to permit such development,
which it may be unable to do; and (iv) that GTx may not be able to
obtain required regulatory approvals to commercialize enobosarm in a
timely manner or at all. GTx’s actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and uncertainties.
You should not place undue reliance on these forward-looking statements,
which apply only as of the date of this press release. GTx’s quarterly
report on Form 10-Q for the quarter ended