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GTx, Inc. (Nasdaq: GTXI) today provided a Company update and reported financial results for the third quarter of 2012.
“We expect to complete enrollment this quarter in our two pivotal Phase III clinical trials evaluating enobosarm for the prevention and treatment of muscle wasting in non-small cell lung cancer patients, and we should receive topline data from these studies during the second quarter of 2013.” said Mitchell S. Steiner, MD, CEO of GTx. “Additionally, we are currently enrolling subjects for our Phase II clinical study of Capesaris
® to demonstrate its safety and efficacy as a secondary hormonal therapy in men with metastatic castration resistant prostate cancer. We believe that the unique mechanism of action of Capesaris will allow it to be used in combination with primary ADT and as the first secondary hormonal therapy used in men with advanced prostate cancer.”
Clinical updatesEnobosarm (Ostarine®, GTx-024), an oral selective androgen receptor modulator, for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer: GTx is currently enrolling subjects with advanced non-small cell lung cancer in two pivotal Phase III clinical trials, POWER 1 and POWER 2. These international Phase III studies are being conducted in clinical sites in the United States, Europe, and South America. In each of the placebo-controlled, double-blind clinical trials, 300 patients with Stage III or IV non-small cell lung cancer are being randomized to oral daily doses of placebo or enobosarm 3 mg at the time they begin first line standard chemotherapy. The studies are evaluating as co-primary endpoints at three months of treatment the response rates of enobosarm versus placebo on maintaining or improving total lean body mass (muscle) assessed by dual x-ray absorptiometry and improving physical function assessed by the Stair Climb Test. Durability of the drug effect is being evaluated as a secondary endpoint at five months of treatment. Enrollment for both studies is expected to be completed in the fourth quarter of this year, and topline results should be released during the second quarter of 2013.
Capesaris® (GTx-758), an oral nonsteroidal selective estrogen receptor alpha agonist, for secondary hormonal therapy in men with castration resistant prostate cancer and, potentially, as a primary treatment for advanced prostate cancer used in combination with ADT: GTx has initiated an open-label, Phase II clinical study of Capesaris to treat men with metastatic castration resistant prostate cancer. The Phase II study will evaluate the safety and effectiveness of three lower doses of Capesaris. The primary endpoint will be to reduce serum prostate specific antigen, or PSA, by day 90. Other key cancer endpoints include serum PSA progression, time to progression and progression free survival in the study subjects. In addition, the clinical study will evaluate the ability of Capesaris to treat certain estrogen deficiency side effects associated with LHRH agonists such as hot flashes, bone loss, and insulin resistance.
Seventy-five men with metastatic castration resistant prostate cancer will be randomized into one of three cohorts of 125 mg, 250 mg or 500 mg daily dose of Capesaris. Each arm will have 25 patients and the enrollment will be conducted sequentially, with the 125 mg cohort being the first to be enrolled. The enrollment into the next higher dose of Capesaris will commence if an acceptable incidence of venous thromboembolic events is observed among randomized patients for 30 days following enrollment of the last patient in the previous cohort.