ARIAD Pharmaceuticals, Inc. (ARIA) announced updated clinical data from the pivotal PACE trial of its investigational pan-BCR-ABL inhibitor, ponatinib, in patients with chronic myeloid leukemia, or CML, or Philadelphia-positive acute lymphoblastic leukemia, who are resistant or intolerant to dasatinib or nilotinib or who have the T315I mutation.
The data shows that 54 percent of chronic-phase CML patients in the trial, including 70 percent of patients who have a T315I mutation, achieved a major cytogenetic response.
ARIAD expects to file for regulatory approval of ponatinib in the U.S. and the EU in the third quarter of 2012 based on these clinical data.
"The findings from the global PACE trial of ponatinib confirm its impressive anti-leukemic activity in patients with CML at all stages who are resistant or intolerant to dasatinib or nilotinib, or who have the T315I mutation for which there are no currently available treatments," stated Jorge Cortes, professor and deputy chair, Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston.
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