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www.fdanews.com/articles/73943-ariad-initiates-phase-ii-clinical-trial-of-ap23573

ARIAD INITIATES PHASE II CLINICAL TRIAL OF AP23573

July 1, 2005

Ariad Pharmaceuticals has announced initiation of enrollment of patients with recurrent or persistent endometrial cancer in a global Phase II clinical trial of its novel mTOR inhibitor, AP23573, as a single agent.

Endometrial cancer is the most common gynecologic malignancy, including ovarian cancer.

This nonrandomized study will evaluate the clinical benefit of AP23573 in well-characterized endometrial cancer patients. Up to approximately 45 patients will be enrolled in the trial at several centers in the U.S. and Europe.

AP23573 will be administered intravenously using a daily dosing regimen. Patients will be followed for at least six months after enrollment but may continue on AP23573 if they have clinical benefit. Data on multiple mTOR-pathway biomarkers, including functional imaging in a subset of patients, will be obtained to help identify patients who are most likely to benefit from treatment with AP23573.