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.
“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.”
"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."
ARIAD Pharmaceuticals, Inc.