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Angiotech Pharmaceuticals and partner Athersys announce positive results from phase I study of MultiStem(R) in heart attack patients
Date:7/28/2010

efficacy signals to facilitate planning for subsequent clinical studies, noting importantly that the study was not powered for efficacy endpoints. Specifically, following a heart attack, patients were screened by left ventriculogram and/or echocardiogram, analyzed at the clinical site, to determine if their LVEFs met inclusion criteria (30 to 45). Prior to MultiStem administration (and between 2-5 days following PCI for registry patients), an additional echocardiogram was performed, which served as the baseline for subsequent analysis. Additional echocardiogram data were collected at prescribed time points according to the protocol. Echocardiogram data collected for each patient were blinded, and evaluated at a central facility.

The preliminary echocardiogram data demonstrated that each group had improvement in mean LVEF at four months compared to mean baseline LVEF. Patients receiving 20, 50, or 100 million MultiStem cells demonstrated absolute improvements in mean LVEF at 4 months of 5.2, 9.8 and 1.5 percentage points, respectively, compared to an absolute improvement of 1.1 percentage points in the registry group. Although the study was not powered for efficacy endpoints, patients in the medium dose group exhibited a statistically significant improvement in LVEF over mean baseline for that group, 9.8 percentage points (p less than 0.02), representing a 23.4% improvement over baseline. The improvement in mean LVEF for each group compared to the registry group, though meaningful, was not statistically significant.

Notably, several patients in the high dose group exhibited substantially higher baseline LVEFs than their initial screening LVEFs, which created a higher baseline mean for that patient group. Including only patients whose baseline LVEFs are less than or equal to 45, the absolute improvements in mean LVEF were 3.9, 13.5 and 10.9 percentage points for the 20, 50, or 100 million dose groups, res
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SOURCE Angiotech Pharmaceuticals, Inc.
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