MEMPHIS, TN, USA I January 13 2016 I GTx, Inc. (Nasdaq: GTXI) today announced the initiation of its Phase 2 clinical trial to treat postmenopausal women with stress urinary incontinence (SUI). The Phase 2 proof-of-concept study of enobosarm (GTx-024) is the first clinical trial to evaluate a selective androgen receptor modulator (SARM) for SUI.
“Given the selective anabolic activity of enobosarm, we are looking forward to evaluating its potential to augment pelvic floor muscle response and potentially improve outcomes for women with stress urinary incontinence,” said Kenneth M. Peters, M.D., Chief of Urology at Beaumont Hospital and the principal investigator in the clinical trial. “I would welcome a safe and effective treatment option, especially since existing non-surgical options are extremely limited and, at times, only marginally effective.”
The trial is a single center, single-arm, open-label proof-of-concept Phase 2 clinical trial evaluating the effects of orally administered enobosarm 3mg in postmenopausal women with SUI. The Company plans to enroll up to 35 patients and evaluate the safety and efficacy of enobosarm. The Company anticipates having top-line results in 2016.
The primary endpoint of the trial is the change in frequency of daily stress urinary incontinence episodes from baseline to week 12. Secondary efficacy endpoints include accepted measurements of voiding, urethral pressure profile and change in pelvic floor muscles as measured by Magnetic Resonance Imaging (MRI).
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, as well as human safety and efficacy data from enobosarm clinical trials involving more than 1,500 subjects. Enobosarm has been found to be generally safe and well tolerated. Following results from the proof-of-concept trial, the Company will determine which GTx SARM compound, including enobosarm, may be further developed for this indication.
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 this proof-of-concept Phase 2 clinical trial in SUI, the Company is conducting a Phase 2 clinical trial of enobosarm 18mg in women with androgen receptor positive (AR+), triple negative breast cancer, as well as a Phase 2 clinical trial of enobosarm 9mg or 18mg in women with estrogen receptor positive (ER+), AR+ breast cancer.
Previously, enobosarm 9mg 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.
SOURCE: GTx
