Published on September 14, 2009 at 8:08 AM
ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced that the independent Data Monitoring Committee (DMC) of the Phase 3 SUCCEED trial has completed the first interim efficacy analysis as specified by the study protocol and has recommended that the randomized, placebo-controlled trial of oral ridaforolimus in patients with metastatic sarcomas 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.
The DMC review comprised approximately one-third of the total number of progression-free survival events anticipated in the trial. The safety and efficacy of oral ridaforolimus is being evaluated in patients with metastatic soft-tissue and bone sarcomas who have achieved a favorable response to chemotherapy. The primary end-point of the trial is progression-free survival.
The DMC indicated that the safety data from the first interim analysis are consistent with the known safety profile of ridaforolimus and that no modifications to the study protocol are recommended. Over 500 patients with metastatic soft-tissue and bone sarcomas have been enrolled in the trial to date. Full patient enrollment is expected to take place by year-end 2009, and the second interim analysis based on approximately two-thirds of the total number of progression-free survival events is expected by the end of the first quarter of 2010, as previously announced.
“The recommendation by the DMC to continue the Phase 3 SUCCEED trial to completion represents an important step in the development of oral ridaforolimus as a potential new treatment option for patients with metastatic sarcomas,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD.
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