Japan is next.
ARIAD Begins Phase 1/2 Trial of Ponatinib in Japan
Trial to evaluate ponatinib in Japanese patients with CML who are resistant or intolerant to prior therapy
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 20, 2012-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today 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 conducted in Japanese patients with chronic myeloid leukemia (CML) who have failed treatment with dasatinib or nilotinib or with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who have failed prior tyrosine kinase inhibitors. The trial is designed to establish the recommended dose for ponatinib and confirm its anti-leukemic activity in Japanese patients. The Company expects that this trial should provide the incremental clinical data needed for initial regulatory approval of ponatinib in Japan. Japan is the third largest CML market in the world with an annual incidence of 1,300 new patients reported in 2010.
“Many of the world’s foremost thought leaders on CML are in Japan, and we are delighted to be collaborating with many of them to advance the potential uses of ponatinib among Japanese patients with refractory CML,” stated Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer of ARIAD. “We are working closely with these CML experts and anticipate that this trial will confirm the results seen with ponatinib in our ongoing Phase 1 and pivotal Phase 2 trials of ponatinib.”
Trial Design
The Phase 1 dose-escalation portion of the trial will have two dose cohorts: 30 mg and 45 mg administered orally once daily. At least six patients will be enrolled in each dose cohort. Once the recommended dose of ponatinib for Japanese patients is determined and safety evaluations have been completed, the Phase 2 portion of the trial will be initiated. The first patient in the trial has been dosed.
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.
For more information about the trial, patients and physicians should visit clinicaltrials.gov/ct2/show/...7133?term=ponatinib&rank=1, call the U.S. toll-free number 1-877-621-2302 or the international number 1-617-621-2302, or e-mail inquiries to clinicaltrials@ariad.com.
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