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January 29, 2014
07:40 EDTGTXIGTx to present GTx-758 Phase 2 clinical trial preliminary findings
GTx announced that it will present preliminary findings from the company’s Phase 2 clinical trial evaluating GTx-758. The Phase 2 clinical trial is sequentially testing for safety and effectiveness of 125mg oral daily dose and 250mg oral daily dose of GTx-758 as secondary hormonal therapy in men with CRPC. The goal of the Phase 2 trial is to show that lower doses of GTx-758 are well tolerated and effective in reducing free testosterone and, in greater than 50% of subjects, achieving a 50% reduction of serum prostate specific antigen by Day 90. Preliminary data shows that a majority of subjects who were experiencing hot flashes prior to taking GTx-758 have reported improvement in and/or stabilization of their hot flashes and bone turnover biomarkers have decreased in a majority of the patients. As for safety, GTx-758 continues to be well tolerated, with no reported venous thromboembolic events or deaths.
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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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