ARIAD TO LAUNCH TRIAL OF TREATMENT FOR SARCOMA

Ariad Pharmaceuticals announced that the Phase III clinical trial of oral AP23573, its novel mTOR inhibitor, will be conducted in patients with metastatic soft-tissue and bone sarcomas by the Sarcoma Alliance for Research through Collaboration in cooperation with other cancer research groups.

The company also reached agreement with the FDA on the design and endpoints of this trial, and a special protocol assessment has been filed based on the primary endpoint of progression-free survival (PFS). Similarly, a request for follow-up protocol assistance has been filed with the European Medicines Agency. The FDA has previously granted fast-track status to AP23573 for the treatment of advanced sarcomas.

Oral 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 randomized to study drug or placebo. The trial is 99 percent powered to detect a 50 percent increase in median PFS comparing the AP23573-treated arm with the placebo arm. Two interim analyses are planned, and patient enrollment is expected to begin by early second quarter of 2007.