14.04.2015 11:28:52
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Mark Your Calendar For Athersys
(RTTNews) - Athersys Inc. (ATHX) is scheduled to present preliminary results from its phase 2 clinical trial of its investigational biologic product for the treatment of ischemic stroke on Sunday, April 19th.
Stroke is a leading cause of serious long-term disability and is the fifth leading cause of death for Americans, according to the Centers for Disease Control and Prevention, or CDC. Every year, more than 795,000 people in the U.S. have a stroke, and almost 130,000 Americans die of stroke. About 87% of all strokes are ischemic strokes - i.e - strokes that occur when the blood supply to the brain is interrupted due to a blood clot.
The experimental product in focus is MultiStem, a proprietary stem cell product that is manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources.
The phase II study of MultiStem for ischemic stroke was initiated in October 2011, and it completed enrollment last December. In this trial, stroke victims were administered MultiStem cells or placebo intravenously one to two days after the stroke had occurred.
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).
Last month, Athersys entered into partnership and license agreement with Chugai Pharmaceutical Co., Ltd. to exclusively develop and commercialize MultiStem cell therapy for ischemic stroke in Japan.
In addition to ischemic strokes, MultiStem is being explored in a range of indications like acute myocardial infarction, graft-versus-host disease and ulcerative colitis, to name a few.
The company plans to launch phase 2 clinical studies of MultiStem in acute myocardial infarction and acute respiratory distress syndrome this year.
A phase II study of MultiStem for ulcerative colitis, conducted by Pfizer Inc. (PFE) under a collaboration and license agreement with Athersys, failed to show meaningful benefit, following a single administration, at eight weeks. The results of this study were announced last April.
The clinical trial results are capable of making or breaking the biotech stocks, and it remains to be seen how the MultiStem trial in ischemic stroke patients pans out.
Will investors applaud the trial results? Stay tuned...
ATHX has traded in a range of $1.08 to $3.43 in the last 1 year.
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