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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