MEMPHIS, Tenn.--(BUSINESS WIRE)--GTx, Inc. (Nasdaq: GTXI) today announced an upcoming podium presentation highlighting the clinical results from the Company’s open-label, Phase 2 proof-of-concept clinical trial evaluating enobosarm 3 mg in postmenopausal women with stress urinary incontinence (SUI). The Company plans to summarize previously presented results, plus present additional data demonstrating duration of response following completion of treatment from women who have now reached seven months post-treatment. The presentation will take place at the 2018 American Urological Association annual meeting being held in San Francisco, CA, from May 18 to 21, 2018.
Details for the 2018 AUA presentation are as follows:
|Abstract:||Oral Enobosarm Shows Promising Activity in Post-Menopausal Women with Stress Urinary Incontinence: Results of a Phase 2 Study|
|Presenter:||Kenneth M. Peters, M.D., Professor and Chairman of Urology|
|Oakland University William Beaumont School of Medicine, Rochester, MI|
|Date:||May 18, 2018 at 10:50 A.M. PT|
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. This clinical trial is closed to enrollment; more information about the clinical trial can be found here.
About the Phase 2 ASTRID Clinical Trial
In addition to the Phase 2 proof-of-concept clinical trial being presented at AUA, GTx also has a larger, ongoing, placebo-controlled Phase 2 clinical trial evaluating enobosarm in postmenopausal women with SUI. The study, called ASTRID (Assessing Enobosarm for Stress Urinary Incontinence Disorder), completed enrollment (n=493) recently and is being conducted at over 60 clinical trial centers across the United States. Top-line results are expected early in the fourth quarter of this year. To learn more about the ASTRID clinical trial, click here.
About Enobosarm and SUI
Enobosarm (GTx-024), a selective androgen receptor modulator (SARM), has been evaluated in 25 completed or ongoing clinical trials enrolling over 2,100 subjects, in which approximately 1,500 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 proof-of-concept Phase 2 clinical trial of enobosarm 3 mg for the treatment of postmenopausal women with 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, 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.
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development and commercialization of medicines to treat serious and/or significant unmet medical conditions, including stress urinary incontinence and prostate cancer.
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) compounds. 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 placebo-controlled clinical 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; and (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 year ended December 31, 2017, contains under the heading, “Risk Factors”, a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.