Ariad to commence ponatinib trial for leukaemias

Specialising in developing new, breakthrough therapies with the potential to transform the lives of patients with difficult-to-treat cancers, the Massachusetts-based company, Ariad Pharmaceuticals, has announced the initiation of the pivotal phase II clinical trial of its investigational pan-BCR-ABL inhibitor, ponatinib (previously known as AP24534), in patients with resistant or intolerant chronic myeloid leukaemia (CML) and Philadelphia positive acute lymphoblastic leukaemia (Ph+ ALL).

The PACE (Ponatinib Ph+ ALL and CML Evaluation) trial is designed to provide definitive clinical data for regulatory approval of ponatinib in this setting. Ponatinib has been granted orphan drug status in both the US and Europe for the treatment of CML and Ph+ ALL.

"The start of the pivotal PACE trial represents an important step in the development of our second molecularly targeted cancer therapy," said Harvey J Berger, Ariad's MD, chairman and chief executive officer.

"With the strong clinical evidence observed to date of haematologic, cytogenetic and molecular anti-leukaemia activity of ponatinib in heavily pre-treated patients with CML, including those patients with the T315I mutation for whom no current treatments are available, we are highly optimistic about the likelihood of success for ponatinib in this registration trial. We also believe that the time to full patient enrolment in this study and to potential regulatory approval of ponatinib will be swift."