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Ariad Begins Patient Enrollment in Two Trials of AP23573, Cytotoxic Agents

April 26, 2005

Ariad Pharmaceuticals has initiated enrollment of advanced cancer patients at major European cancer centers in two multicenter Phase Ib clinical trials of its novel mTOR inhibitor, AP23573, combined with the widely used chemotherapeutic agents, paclitaxel or capecitabine.

These nonrandomized, dose-escalation studies will evaluate the safety and tolerability, pharmacokinetics, and anticancer activity of AP23573 in combination with paclitaxel or capecitabine.

The primary goal of these studies is to determine the optimal dosing regimen for AP23573 when used in combination with each of these cytotoxic drugs, predominantly in patients with progressive breast, ovarian, non-small-cell lung and prostate cancers, as well as certain sarcomas. Up to approximately 110 cancer patients will be enrolled in the two trials at three to five centers in Italy and Switzerland.