ATHX’s phase I clinical trial of MultiStem(NYSE:R), its allogeneic cell therapy product, administered to individuals following acute myocardial infarction (AMI) demonstrate that MultiStem was well tolerated at all dose levels and also suggested improvement in heart function in treated patients.
- Demonstrated 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;
- Patients receiving MultiStem, demonstrated a meaningful improvement in mean wall motion score at 4 months compared to baseline, though this improvement was not statistically significant;
- 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 4 month period, while for registry patients it worsened over this time.
The phase I clinical trial is an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of a single administration of allogeneic MultiStem cells following an AMI.
- Enrolled patients received MultiStem delivered via a catheter into the damaged region of the heart 2-5 days following percutaneous coronary intervention, a standard treatment for heart attack;
- The study includes patients in 3 treatment cohorts or dose groups (20 million, 50 million and 100 million cells per patient) and a registry group where patients received only standard of care.
- 19 treated and 6 registry subjects participated in the study;
- The trial is being conducted at cardiovascular treatment centers in the US, including the Cleveland Clinic, Columbia University Medical Center, Henry Ford Health System, MetroHealth System, Cardiology PC, The Care Group and Hamot Medical Center.
Athersys and Angiotech continue to evaluate the phase I results with study investigators and have begun planning for a subsequent clinical study, which they currently anticipate will be initiated in 2011.