Randomized Global Trial to Evaluate Safety and Efficacy of Iclusig at Three Starting Doses
January 06, 2015 07:35 AM Eastern Standard Time
CAMBRIDGE, Mass.--(BUSINESS WIRE)--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it has concluded consultations with U.S. and European health authorities regarding the design of a randomized, dose-ranging trial to evaluate three starting doses of Iclusig® (ponatinib) in patients with refractory, chronic-phase chronic myeloid leukemia (CP-CML). The trial is expected to inform the optimal use of Iclusig in these patients and will begin by mid-2015. Approximately 450 patients will be enrolled at clinical sites around the world.
“We also anticipate that this trial will give us the opportunity to further explore strategies for dose reductions after patients have achieved a major cytogenetic response in order to maximize an individual’s benefit/risk while on therapy.”
“This clinical trial is expected to provide important data regarding the efficacy of Iclusig treatment initiating at doses less than the currently approved starting dose and maintaining patients on a lower dose. We expect that this will better characterize the safety profile of Iclusig beginning at lower doses,” said Frank G. Haluska, M.D., Ph.D., senior vice president of clinical research and development and chief medical officer at ARIAD. “We also anticipate that this trial will give us the opportunity to further explore strategies for dose reductions after patients have achieved a major cytogenetic response in order to maximize an individual’s benefit/risk while on therapy.”
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