Start of Ariad's Sarcoma Drug Trial May Be Delayed

Ariad Pharmaceuticals announced it has received feedback from the FDA regarding its special protocol assessment on the design and endpoints for its Phase III pivotal trial of oral AP23573, its novel mTOR inhibitor, in metastatic sarcoma.

Based on the FDA's response, the company intends to pursue the trial in the same treatment setting as originally proposed (patients with metastatic sarcoma following a favorable response to chemotherapy), with overall survival as the primary endpoint and progression-free survival as a key secondary endpoint.

As a result, the company anticipates that the initiation of patient enrollment may be delayed from the second to the third quarter of 2007. Ariad expects to provide further details concerning the registration trial based on receipt of follow-up protocol assistance from the European Medicines Agency and ongoing interactions with the FDA.

Under the originally proposed trial design, AP23573 will be compared with placebo in patients with metastatic sarcomas who had a favorable response to first-line or second-line chemotherapy during a time frame when they normally would not receive other therapies. Approximately 500 patients at 50 to 75 sites worldwide will be enrolled, and two interim analyses are planned.