Ariad Pharmaceuticals Inc. has received feedback from the US Food and Drug Administration (FDA) regarding its Special Protocol Assessment on the design and endpoints for its phase 3 pivotal trial of oral AP23573, its novel mTOR inhibitor, in metastatic sarcoma.
Based on the FDA's response, the company intends to pursue its phase 3 trial in the same treatment setting as originally proposed (patients with metastatic sarcoma following a favourable 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 initiation of patient enrolment may be delayed from the second to the third quarter of 2007. The company expects to provide further details concerning the registration trial based on receipt of follow-up Protocol Assistance from the European Medicines Agency (EMEA) and ongoing interactions with the FDA.
"We are working to ensure that our pivotal trial for AP23573 conforms to the guidance and requirements put forth by both the US and European regulatory agencies and will initiate patient enrolment as soon as possible," said Harvey J. Berger, MD, chairman and chief executive officer of Ariad.
ARIAD is engaged in the discovery and development of breakthrough medicines to treat cancer by regulating cell signaling with small molecules. The company is developing a comprehensive approach to patients with cancer that addresses the greatest medical need - aggressive and advanced-stage cancers for which current treatments are inadequate.