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June 2, 2014
11:03 EDTGTXIGTx reports results from Phase 2 study of enobosarm
GTx, Inc. announced positive results from a Phase 2, proof-of-concept, open-label clinical study evaluating enobosarm, a selective androgen receptor modulator, for the treatment of patients with androgen receptor positive and estrogen receptorpositive metastatic breast cancer who have previously responded to hormonal therapy. The clinical data is being presented today during the Breast Cancer-HER2/ER poster session at the 50th Annual Meeting of the American Society of Clinical Oncolog in Chicago. The Phase 2 open-label study is evaluating 22 postmenopausal women with ER positive metastatic breast cancer, who had previously responded to adjuvant hormonal therapy for three years or longer, and women diagnosed with metastatic disease, who had been treated with hormonal therapy for at least six months, prior to disease progression. Study participants were heavily pretreated. The mean time from initial breast cancer diagnosis is 11 years and the mean age of patients is 64 years. Of the 22 patients enrolled in the study, a total of 20 patients had one or more scheduled assessments for determination of clinical benefit. The primary endpoint was assessed in 17 AR+ patients with 6 patients demonstrating clinical benefit at six months, exceeding the pre-defined statistical threshold requiring that at least 3 of 14 patients with an AR+ metastatic lesion demonstrate clinical benefit. Additionally, results showed that, after a median duration on study of 81 days, 41 percent of all patients achieved clinical benefit as best response and also had increased prostate specific antigen, which appears to be an indicator of AR activity.
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October 6, 2015
07:04 EDTGTXIGTx says first patient enrolled in Phase 2 trial of TNBC treatment
GTx announced the enrollment of the first patient into its Phase 2 clinical trial of enobosarm to treat women with advanced, androgen receptor positive, triple negative breast cancer, or 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, AR+ breast cancer, which the company recently announced had also enrolled its first patient. The open-label, multi-center, multinational Phase 2 clinical trial 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 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.
September 29, 2015
07:02 EDTGTXIGTx announces enrollment of first patient in Phase 2 Enobosarm trial
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