Market Overview

Athersys Finishes Enrollment of Phase 2 Study of MultiStem(R) Cell Therapy for Ischemic Stroke


Athersys, Inc. (Nasdaq: ATHX)
today announced that it has concluded patient enrollment of its Phase 2
clinical study involving administration of Athersys' MultiStem^® cell therapy
to ischemic stroke patients. The study is a randomized, double-blind,
placebo-controlled, multi-center clinical trial evaluating the safety and
efficacy of MultiStem therapy in subjects suffering moderate to
moderate-severe ischemic strokes. Athersys expects initial results from the
study to be disclosed around the end of the first quarter of 2015.

"With enrollment now finished, we look forward to the initial 90-day results
from this study," commented Dr. Gil Van Bokkelen, Chief Executive Officer at
Athersys. "An ischemic stroke can be a devastating event for a patient, and
effective treatments for stroke are limited, resulting in substantial
opportunities for new therapies. Based upon MultiStem's preclinical efficacy
profile, its novel mechanisms of action, and a favorable safety profile
demonstrated in preclinical and clinical settings, we believe that MultiStem
could provide meaningful benefit to these patients. The results from this
study are expected to provide significant insight into the potential for
MultiStem therapy for the treatment of ischemic stroke."

Ischemic stroke is caused by a blockage of blood flow to the brain. A leading
cause of death and disability globally, each year more than 15 million people
are estimated to suffer a stroke, including more than two million people in
the United States, Japan and European Union, combined. According to the
American Heart Association, ischemic strokes comprise more than 85% of all
strokes. Current standard of care for ischemic stroke involves the
administration of a thrombolytic (clot dissolving) agent within three to four
hours after a stroke has occurred, a narrow window that results in only a
small percentage of patients receiving such treatment.

In this Phase 2 trial, stroke victims were administered MultiStem cells or
placebo intravenously one to two days after the stroke had occurred. If this
study shows that MultiStem treatment is both safe and effective following such
administration, as was demonstrated in non-clinical studies, the treatment
window could be expanded significantly, from hours to days, providing an
important new therapeutic option for stroke patients. Based on preclinical
studies, Athersys believes that MultiStem treatment has the potential to
substantially improve neurological and functional recovery following stroke by
attenuating the inflammatory activity that follows the stroke, accelerating
the return to immune system homeostasis, supporting protection of at-risk
neurons, and by supporting conditions for neuronal recovery and growth,
thereby enhancing repair and patient recovery. The MultiStem treatment's
potential multidimensional impact distinguishes the cell therapy from other
pharmaceutical therapies focused on a single mechanism of benefit.

The randomized, double-blind, placebo-controlled Phase 2 clinical trial is
being conducted by Athersys at sites in the United States and United Kingdom,
and has enrolled subjects who received either MultiStem treatment or placebo
one to two days following the stroke. The primary endpoints for the study
include safety over the first seven days following treatment and global stroke
recovery at day 90, which assesses global disability (modified Rankin Score),
neurological deficit (NIH stroke scale) and activities of daily living
(Barthel Index). Additionally, there are multiple secondary and exploratory
endpoints evaluating multiple elements of recovery and dysfunction, including
biomarkers associated with the condition and recovery, and safety variables
over the study period.

Posted-In: News Press Releases


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