ARIAD Pharmaceuticals, Inc. (ARIA) announced the initiation of a multi-center Phase 1/2 clinical trial in Japan of ponatinib, the company's investigational BCR-ABL inhibitor. The trial is being carried out in Japanese patients with chronic myeloid leukemia, or CML, who have failed treatment with dasatinib or nilotinib or with Philadelphia-chromosome positive acute lymphoblastic leukemia, or Ph+ ALL, who have failed prior tyrosine kinase inhibitors.
According to the company, the trial is designed to establish the recommended dose for ponatinib and confirm its anti-leukemic activity in Japanese patients. ARIAD expects that this trial should provide the incremental clinical data needed for initial regulatory approval of ponatinib in Japan.
The single-arm, open-label Phase 2 component of the trial is expected to begin in the first quarter of 2013 and to enroll an additional 25 adult patients. ARIAD expects to fully enroll the study by mid-year 2013. In the Phase 2 portion of the trial, the primary efficacy endpoint for CML patients in chronic phase will be major cytogenetic response. For CML patients in accelerated phase or blast phase and for Ph+ ALL patients, the primary endpoint will be major hematologic response, defined as complete hematologic response or no evidence of leukemia.
The study's secondary endpoints for all patients will include major molecular response, time to response, duration of response, progression-free survival and overall survival.
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