Athersys' Phase I Study Of MultiStem In Heart Attack Patients Presented At Transcatheter Cardiovascular Therapeutics Conference 2010
CLEVELAND, Sept. 23, 2010 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) announced at its presentation at the Transvascular Cardiovascular Therapeutics (TCT) Conference held in Washington, D.C., updated results from its phase I clinical trial of MultiStem ®, its allogeneic cell therapy product, administered to individuals following acute myocardial infarction (AMI). Dr. Marc Penn, M.D., Ph.D., co-principal investigator of this study and Director of Cardiovascular Cell Therapy at the Cleveland Clinic, and Director of the Skirball Laboratory for Cardiovascular Cellular Therapeutics presented the results at the Symposium "Strategies for Cardiovascular Repair: Stem Cell Therapy and Beyond." The study results, based on four months of post-treatment patient data, demonstrate that MultiStem was well tolerated at all dose levels and also suggest improvement in heart function in treated patients.
New data presented by Dr. Penn included additional information about the nature and incidence of adverse events (AEs) over the first four months of the trial, demonstrating that the AEs were generally mild-to-moderate in nature, there was no dose dependent effect of MultiStem on AEs, and overall, MultiStem had a favorable safety profile. Further, Dr. Penn shared the results from additional analysis of echocardiogram data collected over the first four months of the study, which suggests that MultiStem administration may also provide improvements in other measures of heart function. Patients receiving MultiStem, for instance, demonstrated a meaningful improvement in mean wall motion score at four months compared to baseline, though this improvement was not statistically significant. Interestingly, among those patients with more severe heart attacks (i.e. left ventricular ejection fraction (LVEF), a measure of heart function, less than or equal to 45), the mean wall motion score for treated patients improved over the four-month period, while for registry patients it worsened over this time.
"We are continuing to see strong findings from this phase I study that suggest that MultiStem is well tolerated and that administration following a heart attack could provide a meaningful improvement in functional heart measures," said Dr. Penn. "These data are the first from a human trial that match the magnitude of effect seen in the preclinical studies, and support further evaluation of MultiStem as a safe and effective treatment following heart attack."
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