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 (SUFU) Meeting

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, TN, USA I February 24, 2016 I 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.

Poster:           #BS22
            Non-Steroidal Tissue-Selective Androgen Receptor Modulators (SARMs) Increase Pelvic Floor Muscle Mass in Female Ovariectomized Mice
Presenter:           Ramesh Narayanan, Ph.D., Director, Center for Cancer Drug Discovery and Associate Professor, Department of Medicine, University of Tennessee and Consultant for GTx, Inc.
Date:           Wednesday, February 24, 2016

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.


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