Biotech Values

[DonShimoda]

ARIAD Announces Initiation of Ponatinib (AP24534) Pivotal Trial

Interesting trial design:

"The PACE trial is a global, single-arm clinical study of oral ponatinib in 320 patients with chronic phase, accelerated phase, or blast phase CML, as well as Ph+ ALL. Patients resistant or intolerant to dasatinib (Sprycel®) or nilotinib (Tasigna®), or with T315I mutation of BCR-ABL, will be enrolled in the trial. Patients will be grouped into one of six separate cohorts based on their phase of CML (i.e., chronic, accelerated or blast) and BCR-ABL mutation status (i.e., with or without the T315I mutation); Ph+ ALL patients will be grouped with blast phase CML. A total of 160 patients with chronic phase CML will be included. The primary endpoints are major cytogenetic response rate for chronic phase patients and major hematologic response rate for accelerated or blast phase CML patients and Ph+ ALL patients. Secondary endpoints in the trial include major molecular response rate, duration of response, progression-free survival, and overall survival."

ARIAD anticipates that it will be able to submit data from this single-arm trial with six months of follow-up response data.

http://finance.yahoo.com/news/ARIAD-Announces-Initiation-of-bw-1856153256.html?x=0&.v=1