MEMPHIS, Tenn.--(BUSINESS WIRE)--GTx, Inc. (Nasdaq: GTXI) today reported financial results for the first quarter of 2017, and highlighted recent accomplishments and upcoming milestones. The Company has two ongoing clinical trials of enobosarm (GTx-024) as a potential treatment in women with advanced breast cancer and one ongoing trial with enobosarm as a potential treatment for stress urinary incontinence (SUI) in postmenopausal women. The Company is also completing preclinical studies in its Selective Androgen Receptor Degrader (SARD) program that are required prior to initiating a clinical trial in men with castration-resistant prostate cancer (CRPC), which is planned for the first half of 2018.
“We look forward to several important data milestones during this year. This includes top-line results which we expect to announce in the third quarter of this year from an ongoing Phase 2 trial of enobosarm in women with advanced, ER+, AR+ breast cancer and from our clinical trial to treat postmenopausal women with SUI. We also continue to generate interest in the SARD program, which is focused on developing a novel treatment for advanced prostate cancer.” said Robert J. Wills, Ph.D., Executive Chairman of GTx.
Corporate Highlights and Anticipated Milestones
Enobosarm in Breast Cancer: The Company’s lead product candidate, enobosarm, a selective androgen receptor modulator (SARM), is being developed as a targeted treatment for two advanced breast cancer indications: (i) estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer, and (ii) AR+ triple negative breast cancer (TNBC). For both clinical trials, the primary efficacy endpoint is a determination of clinical benefit (CB), which is defined as a complete response, partial response or stable disease.
ER+/AR+ breast cancer: The Company has an ongoing open-label, multi-center Phase 2 clinical trial of enobosarm in women with advanced, ER+, AR+ breast cancer. Patients receive orally-administered enobosarm (9 mg or 18 mg) daily for up to 24 months. The two dose cohorts in the trial are being treated independently for the purpose of assessing efficacy. The study is fully enrolled and the Company expects to report top-line results from this study in the third quarter of 2017.
AR+ TNBC: The Company also has an ongoing open-label, multi-center Phase 2 clinical trial to evaluate the efficacy and safety of an orally-administered 18 mg dose of enobosarm in up to 55 women with advanced, AR+ TNBC. The primary efficacy objective of the trial is CB response following 16 weeks of treatment in 41 evaluable patients. The Company expects to have sufficient data from Stage 1 of the trial later this quarter to determine if patient enrollment should continue into Stage 2 of the trial.
SARMs in Non-Oncologic Indications: The Company also is developing SARMs as potential treatments for both stress urinary incontinence (SUI) in postmenopausal women and Duchenne muscular dystrophy (DMD), a rare disease characterized by progressive muscle degeneration and weakness.
Stress Urinary Incontinence: Earlier this year, the Company announced it has added additional clinical sites to its ongoing Phase 2 proof-of-concept clinical trial of 3 mg of enobosarm in postmenopausal women with SUI. These sites are now enrolling patients, and the Company expects to announce top-line results from this trial in the third quarter of 2017.
- An abstract on preliminary data from the ongoing Phase 2 clinical trial has been accepted for podium presentation at the annual meeting of the International Continence Society in Florence, Italy on September 13, 2017. The principal investigator, Dr. Kenneth Peters, will present these encouraging data from the first cohort of patients enrolled in the study.
