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Stage 1 milestone met in GTx's mid-stage study of lead product candidate in certain type of breast cancer, trial to advance to Stage 2

Published 11/16/2016, 07:43 AM
Stage 1 milestone met in GTx's mid-stage study of lead product candidate in certain type of breast cancer, trial to advance to Stage 2
ONCT
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  • GTx (NASDAQ:GTXI) announces that the Stage 1 milestone of a pre-defined number of patients showing clinical benefit from treatment with 18 mg of enobosarm (GTx-024) has been achieved in its open-label Phase 2 clinical trial in women with advanced, estrogen receptor-positive (ER+), androgen receptor-positive (AR+) breast cancer. Per the protocol, the study will now advance to the second and final stage for the 18 mg cohort.
  • In September, the Stage 1 milestone was achieved for the 9 mg cohort. Stage 1 data will be reported next month.
  • The mid-stage study is assessing the safety and efficacy of orally administered enobosarm (9 mg or 18 mg once daily) in up to 88 evaluable metastatic or locally advanced ER+/AR+ breast cancer patients. If at least three of the first 18 subjects achieve clinical benefit at week 24, then the trial may proceed to the second stage. Clinical benefit is defined as a complete response, partial response or stable disease at week 24 (this is also referred to as the disease control rate). This is the primary endpoint.
  • According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is February 2017. The estimated study completion date is August 2018.
  • Enobosarm is a non-steroidal androgen receptor agonist. It may offer an alternative hormonal approach for the treatment of endocrine-sensitive advanced breast cancer prior to chemotherapy.
  • Previously: GTx's enobosarm shows positive results in mid-stage breast cancer study; shares up 47% (Sept. 8)

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