Pipeline updates are highly awaited events in the
pharma/biotech sector as they play an important role in deciding
whether or not to invest in a particular company. These updates
provide information on experimental drugs and at times give an
insight into the commercial potential of the candidate once it is
successfully developed and commercialized.
) announced the completion of the enrolment process of a phase II
study on its MultiStem cell therapy. Athersys is developing
MultiStem for ulcerative colitis in collaboration with
). The randomized, double-blind, placebo-controlled, multi-center
phase II study will evaluate the safety and efficacy of MultiStem
therapy in patients suffering from moderate-to-severe ulcerative
The primary objective of the study is to evaluate the incidence
and severity of adverse events over 16 weeks. Moreover, it will
also evaluate the change in endoscopic score (measured by
modified Baron score) at the end of 8 weeks along with changes in
the Mayo rectal bleeding sub-score at weeks four and eight.
Athersys will also evaluate disease indicators and markers over
the study duration.
Athersys intends to announce the results from the phase II study
in two parts with the initial results expected around April or
May next year. The next part results are expected to be available
towards the end of the second quarter of 2014.
We note that Athersys is also developing MultiStem for treating
inflammatory bowel disease, ischemic stroke, damage caused by
myocardial infarction, and for the prevention of
graft-versus-host disease (GvHD). Earlier in the month, MultiStem
was granted orphan drug designation in Europe for the GvHD
indication. The candidate already has an orphan drug designation
in the U.S. for this indication.
We are encouraged by the pipeline progress at Athersys. We expect
investor focus to stay on the company's pipeline going forward.
Athersys carries a Zacks Rank #3 (Hold). However, some
better-ranked stocks include
Vanda Pharmaceuticals, Inc.
). Both stocks carry a Zacks Rank #1 (Strong Buy).
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