GTXI .95 GTx Achieves Stage 1 Milestone in Phase 2 Clinical Trial of Enobosarm in ER+/AR+ Breast Cancer
GTx, Inc. (Nasdaq: GTXI) today announced the achievement of the Stage 1 milestone for the 9 mg cohort of its Phase 2 clinical trial of enobosarm (GTx-024) to treat women with advanced, estrogen receptor positive (ER+), androgen receptor positive (AR+) breast cancer. A pre-defined number of patients demonstrated clinical benefit per protocol to allow the clinical trial to advance to the second and final stage of the trial (Stage 2). GTx also expects to provide an update on Stage 1 of the second dosing cohort (18 mg) in the clinical trial once there are sufficient evaluable patients to assess clinical benefit in this cohort. The Company anticipates reporting Stage 1 data from the clinical trial in the fourth quarter of 2016.
"The demonstration of clinical benefit among a pre-defined number of evaluable patients in Stage 1 of the 9 mg cohort of our ER+/AR+ breast cancer study represents an important milestone for GTx since we have met the protocol specified success criteria to continue with enrollment in Stage 2 of this cohort," said Robert J. Wills, Ph.D., Executive Chairman of GTx. "We believe enobosarm may provide a new hormonal approach for the treatment of estrogen receptor positive breast cancer and may delay the need for chemotherapy in these women."
