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|GTx Announces Acceptance of an Abstract on Preliminary Results from Phase 2 Clinical Trial in Women with Stress Urinary Incontinence at the International Continence Society Annual Meeting|
-- Podium presentation to outline data from an ongoing clinical trial of enobosarm to treat stress urinary incontinence in postmenopausal women --
-- Presentation to take place on
The clinical data will be reviewed during a podium presentation at the
“We are encouraged with the preliminary data from our ongoing Phase 2
clinical trial and believe that enobosarm may represent a unique first
in class oral therapeutic for the treatment of SUI,” said Dr.
About the Phase 2 Proof-of-Concept Clinical Trial
Enrollment in the Phase 2 proof-of-concept clinical trial of 3 mg of enobosarm in women with SUI is ongoing. This is the first clinical trial to evaluate a SARM for SUI. The Company believes that developing an oral therapy to treat the large number of women who face a diminished quality of life from stress urinary incontinence presents a unique commercial opportunity, especially since current therapies may sometimes involve invasive procedures.
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, of 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 data from the Company’s ongoing Phase 2 clinical trial continues to validate the use of enobosarm as a potential treatment for SUI.
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 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.
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 development of its selective androgen receptor
modulator (SARM) assets. 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 the Phase 2 proof-of concept
study being conducted by GTx for the treatment of stress urinary
incontinence (SUI) may not be completed on schedule; (ii) that additional
clinical development of GTx’s SARM compound for the treatment of SUI
will be required beyond the ongoing study; (iii) any future development
of SARMs in SUI is contingent on obtaining sufficient additional capital
to permit such development, which it may be unable to do. In addition,
GTx will continue to need additional funding and may be unable to raise
capital when needed, which would force GTx to delay, reduce or eliminate
its product candidate development programs and potentially cease
operations. 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 annual report on Form 10-K for the