ARIAD Pharma initiates multi-centre phase I/II clinical trial in Japan of Ponatinib
Emerging global oncology company ARIAD Pharmaceuticals, Inc has begun multi-centre phase I/II clinical trial in Japan of ponatinib, the investigational BCR-ABL inhibitor, the news reports said.
The trial is being conducted in Japanese patients suffering from chronic myeloid leukaemia who have failed treatment with dasatinib or nilotinib or with Philadelphia-chromosome positive acute lymphoblastic leukaemia who have failed prior tyrosine kinase inhibitors.
The trial has been designed to establish the recommended dose for ponatinib and confirm its anti-leukaemic activity in Japanese patients.
The company expects that this trial would provide the incremental clinical data needed for initial regulatory approval of ponatinib in Japan.
Timothy P Clackson, PhD, President of research and development and chief scientific officer of ARIAD said, “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.” Mr. Clackson also said, “We are working with these CML experts and anticipate that this trial will confirm the results seen with ponatinib in our ongoing phase 1 and pivotal phase II trials of ponatinib.”
The phase 1 dose-escalation portion of trial will have two dose cohorts namely 30mg and 45mg administered orally once daily.
The single-arm, open-label phase II component of the trials is expected to start in the first quarter of 2013 and to enroll in more 25 adult patients.
ARIAD aims to completely enroll the study by mid-year 2013.
The study’s secondary endpoints for all the patients will include major molecular response, time to response, duration of response, progression-free survival and overall survival.
ARIAD Pharmaceuticals, Inc is a small pharmaceutical company working on cancer drugs. The company is located in Cambridge, Massachusetts and was established in 1991 by Larry Bock, David Blech and Harvery Berger. It also has strong partnerships with Merck.