) recently announced the publishing of results from a phase I
dose-escalation study of ponatinib in the
New England Journal of Medicine
. Ponatinib, a tyrosine kinase inhibitor, is being developed for
use in heavily pretreated patients, suffering from resistant and
refractory chronic myeloid leukemia (CML) and Philadelphia
chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
ARIAD enrolled 81 patients with resistant hematologic cancers
for the study. Of these, 60 patients had CML and five of them
were suffering from Ph+ ALL. After 72 weeks, 72% of the
chronic-phase CML patients (31 of 43), who enrolled for the
study, experienced a major cytogenetic response (MCyR).
ARIAD reported some dose-limiting toxicities in the study,
which included elevated lipase or amylase levels and
pancreatitis. The study also had adverse events, such as rash,
thrombocytopenia and arthralgia among others.
We note that ponatinib is currently under US Food and Drug
Administration (FDA) review for patients suffering from resistant
or CML or Ph+ ALL. A decision on ponatinib is expected from the
US regulatory body by March 27, 2013.
In August this year, ARIAD submitted a Marketing Authorization
Application (MAA) for ponatinib for the same indication to the
European Medicines Agency (EMA). ARIAD had requested accelerated
assessment of the MAA for the candidate, which was granted by the
Committee for Medicinal Products for Human Use (CHMP).
ARIAD also intends to commercialize ponatinib beyond Europe
and the US. In August this year, the company initiated a
multi-center phase I/II clinical trial with ponatinib in Japan,
one of the largest CML markets in the world.
The Japanese trial is evaluating ponatinib in patients with
CML, who have failed treatment with
Bristol-Myers Squibb Company
) Sprycel (dasatinib) or
) Tasigna (nilotinib) or with Ph+ ALL, who have failed treatment
with tyrosine kinase inhibitors.
We currently have a Neutral recommendation on ARIAD. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.
ARIAD PHARMA (ARIA): Free Stock Analysis
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