ARIAD Pharmaceuticals, Inc. (
recently completed 50% enrollment in the randomized phase III
EPIC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid
Leukemia) study being conducted on Iclusig (ponatinib) in newly
diagnosed chronic myeloid leukemia (CML) patients. EPIC will
evaluate treatment-naive CML patients.
The randomized (1:
), two-arm, multicenter EPIC study will compare the efficacy of
Iclusig with that of
Gleevec (imatinib) in newly diagnosed in adult CML patients. Full
enrolment of 500 patients is likely to complete by the end of
The primary endpoint of the study is major molecular response
(MMR) of patients at 1 year of treatment. Main secondary
endpoints include MMR at five years and molecular response (MR)
at three months of treatment.
Interim analysis of the study is due in the third quarter of
Iclusig, a tyrosine kinase inhibitor (TKI), launched in the
U.S. in Jan 2013, is currently marketed by Ariad for treating
adults suffering from CML, and Philadelphia chromosome-positive
acute lymphoblastic leukemia (Ph+ ALL), who are resistant or
intolerant to TKI therapy. Ariad recorded Iclusig sales of $13.9
million in the second quarter of 2013.
In Jul 2013, Ariad gained EU approval for Iclusig in two
indications. The first indication is the treatment of chronic
phase, accelerated phase or blast phase CML in adults who do not
respond to or cannot tolerate Sprycel or Tasigna. It is also
approved for patients in whom Gleevec is not appropriate as a
subsequent treatment. The second indication covers the treatment
of Ph+ ALL in adults unresponsive to Sprycel. It also includes
patients for whom Gleevec is not clinically appropriate. Iclusig
is also approved for patients who have the T315I mutation.
Ariad currently carries a Zacks Rank # 3 (Hold). Other stocks
that look attractive include
Biogen Idec Inc
. Both carry a Zacks Rank #1 (Strong Buy).
AFFYMETRIX INC (AFFX): Free Stock Analysis
ARIAD PHARMA (ARIA): Free Stock Analysis
BIOGEN IDEC INC (BIIB): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
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