GTx Announces Presentation of Preclinical Data Demonstrating the Effect of GTx SARMs on Pelvic Floor Muscle Loss at the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SU

GTx-024 (enobosarm) and GTx-027 reverse the observed loss of pelvic floor muscle in an animal model

Preclinical data supports recently initiated Phase 2 clinical trial in postmenopausal women with stress urinary incontinence

MEMPHIS, Tenn.--(BUSINESS WIRE)-- GTx, Inc. (Nasdaq: GTXI) today announced preclinical data demonstrating that two of the Company’s selective androgen receptor modulators (SARMs), GTx-024 (enobosarm) and GTx-027, are able to increase pelvic floor muscle mass as well as turn off genes that are associated with muscle degradation in an ovariectomized mouse model. This model approximates the pelvic floor changes that can be associated with stress urinary incontinence (SUI) in postmenopausal women.

The preclinical data are being presented today at the Winter Meeting of the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) taking place February 23-27, 2016, in New Orleans, La.

According to Dr. Narayanan, “These results demonstrate the ability of these SARMs to restore the pelvic floor muscles to their normal weight and provide support for a potential role of these compounds in the treatment of SUI.”

GTx Inc. is currently conducting a Phase 2 proof-of-concept clinical trial to evaluate effects of orally administered enobosarm 3 mg in 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.

About the Enobosarm Clinical Development Program

In addition to the proof-of-concept Phase 2 clinical trial in SUI, the Company is conducting a Phase 2 clinical trial of enobosarm 18 mg in women with androgen receptor positive (AR+), triple negative breast cancer, as well as a Phase 2 clinical trial of enobosarm 9 mg or 18 mg in women with estrogen receptor positive (ER+), AR+ breast cancer.

Previously, enobosarm 9 mg has been tested in 22 postmenopausal women with ER+ metastatic breast cancer in a Phase 2 clinical trial. In total, enobosarm has been evaluated in clinical trials enrolling over 1500 subjects at doses ranging from 0.1 mg to 100 mg. At all evaluated dose levels, enobosarm was observed to be safe and well tolerated.

About GTx

GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development and commercialization of small molecules for the treatment of cancer, including treatments for breast and prostate cancer, and other serious medical conditions.

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 clinical trial of enobosarm (GTx-024) to treat stress urinary incontinence (SUI) as well as its clinical trials of enobosarm to treat patients with advanced breast cancer. 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 any additional clinical development of GTx’s product candidate, enobosarm, beyond the clinical trial to treat SUI and its two Phase 2 clinical trials of enobosarm in patients with AR positive advanced breast cancer, 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; or (iii) that GTx may not be able to obtain required regulatory approvals to commercialize its product candidates in a timely manner or at all. 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 quarterly report on Form 10-Q for the quarter ended September 30, 2015, filed November 9, 2015, 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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160224005155/en/

Investors
GTx, Inc.
Lauren Crosby, 901-271-8622
[email protected]
or
Media
Red House Consulting
Denise Powell, 510-703-9491
[email protected]

Source: GTx, Inc.

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