Ariad Pharmaceuticals Inc.
) shares slipped approximately 66% on Oct 9, 2013 to close at
$5.83 following the company's announcement that the U.S. Food and
Drug Administration has placed a partial clinical hold on
enrolling new patients in studies on its oncology drug
Iclusig due to safety issues.
However, the company will resume studies after dose changes,
including reduction in the current 45 mg daily dose of Iclusig
and other modifications depending upon agreement with the
Additionally, the dosage of Iclusig in the EPIC study will be
reduced to 30 mg daily unless the patients achieve a major
molecular response. The dose will be further reduced to 15 mg
daily once the patients are successful in achieving such
response. These changes are in line with the Data
Monitoring Committee's recommendation.
Iclusig is currently in the phase III EPIC study, in which it
is being compared to
) Gleevec (imatinib) in patients with newly diagnosed chronic
myeloid leukemia (CML). Ariad is presently enrolling patients for
the study with interim data likely to come out in the third
quarter of 2014.
Furthermore, according to the changes announced, patients who
have suffered heart attack or stroke due to arterial thrombosis
will now be ineligible for inclusion in the Iclusig study.
In Jul 2013, Ariad gained EU approval for Iclusig for a couple
of 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 #4 (Sell). Currently,
stocks which look more attractive include
) with a Zacks Rank #1 (Strong Buy) and
Alexion Pharmaceuticals, Inc.
) with a Zacks Rank #2 (Buy).
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