ARIAD Pharmaceuticals completes enrollment of patients for Phase 3 clinical trial of ridaforolimus

Dec 18 2009

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the completion of patient enrollment in its pivotal, Phase 3 clinical trial of oral ridaforolimus, its investigational mTOR inhibitor, in patients with metastatic soft-tissue and bone sarcomas. The Company believes that this international study is the largest clinical trial to be conducted in patients with sarcomas. It was initiated in September, 2007 and took just over two years to fully accrue.

“We are extremely proud of this accomplishment,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “Achieving full patient enrollment in the SUCCEED clinical trial was a major global undertaking, and our many R&D groups deserve tremendous recognition for their work. We are very pleased to have achieved this milestone in the timeframe that we established at the outset and now look forward to completing the trial and reporting data from the study next year.”

The SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus) trial is a randomized, double-blind, placebo-controlled Phase 3 study of oral ridaforolimus in patients with metastatic sarcoma who have benefited from prior chemotherapy. The primary endpoint of the trial is progression-free survival (PFS).

The trial is designed to assess approximately 650 patients who are randomized (1:1) to oral ridaforolimus or placebo at approximately 145 sites in nearly 25 countries. The trial is 90 percent powered to detect a 33 percent increase in median progression-free survival (corresponding to a hazard ratio of 0.75) comparing the ridaforolimus arm with the placebo arm.

In September, the independent Data Monitoring Committee (DMC) of the SUCCEED trial completed the first interim efficacy analysis as specified by the study protocol and recommended that the trial continue to full patient enrollment and completion. The DMC made this recommendation after reviewing the pre-specified statistical analyses and available data on the safety and efficacy of oral ridaforolimus. A second interim efficacy analysis is expected at approximately the end of the first quarter of 2010 based upon approximately two-thirds of the total number of progression-free survival events anticipated in the trial. Final data analysis from the SUCCEED trial is expected in the second half of 2010.

ARIAD has a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration for the SUCCEED trial. The European Medicines Agency has provided protocol advice regarding the trial design as part of its Protocol Assistance program.

ARIAD and its partner, Merck & Co., Inc., have a global collaboration to jointly develop and commercialize ridaforolimus in oncology.