GTx Announces Enrollment of First Patient in Phase 2 Clinical Trial of Enobosarm in Triple Negative Breast Cancer

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GTx, Inc.
GTXI
today announced the enrollment of the first patient into its Phase 2 clinical trial of enobosarm (GTx-024) to treat women with advanced, androgen receptor positive (AR+), triple negative breast cancer (TNBC). Enobosarm is the Company's lead product candidate and is also being evaluated in a separate Phase 2 clinical trial to treat estrogen receptor positive (ER+), AR+ breast cancer, which the Company recently announced had also enrolled its first patient. "Most women with triple negative breast cancer have extremely limited treatment options and poor prognoses," said Robert J. Wills, Ph.D., Executive Chairman of GTx. "Based on our preclinical research and positive data from patient-derived and cell line-derived xenografts of TNBC, we are hopeful that enobosarm, by targeting the androgen receptor, may offer another treatment option to women with this disease." The open-label, multi-center, multinational Phase 2 clinical trial (NCT02368691) will evaluate the efficacy and safety of orally administered enobosarm in up to 55 women with advanced, AR+ TNBC. Patients will receive 18 mg of enobosarm once daily for up to 12 months. The initial stage will be assessed among the first 21 evaluable patients. If at least 2 of 21 patients achieve clinical benefit at week 16, then the trial will proceed to the second stage of enrollment of up to a total of 41 evaluable patients. Clinical benefit is defined as a complete response, partial response, or stable disease, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) at 16 weeks. The trial, which is being conducted under the leadership of Dr. Hope Rugo from the University of California at San Francisco, will include investigators from more than 40 clinical trial sites in the U.S. and abroad.
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