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.