AMR-001: Additional Phase II data

Additional data from the double-blind, U.S. Phase II PreSERVE AMI trial in 161 patients diagnosed with an ST-segment elevation myocardial infarction (STEMI) showed that intracoronary AMR-001 given 5-11 days post-stent placement led to a mean reduction in myocardial perfusion as measured by RTSS using SPECT MPI from baseline to 6 months, the primary endpoint, of 149.6 points vs. 142.7 points for placebo. AMR-001 increased LVEF from baseline to 6 months, a secondary endpoint, by 3.1% at a dose of <14 million cells, by 5.8% at a dose of >14 million cells and by 10.2% at a dose of >20 million cells vs. 4.9% for placebo (p<0.05 for high dose AMR-001 vs. placebo). AMR-001 also led to reductions in infarct size from baseline to 6 months of 16% at the low dose, 35% at the mid dose and 41% at the high dose vs. 24% for placebo. Additionally, patients receiving low-, mid- and high-dose AMR-001 experienced 164.4, 167.5 and 167.6 days alive and out of the hospital, respectively, vs. 160.5 days for placebo (p=0.04 for both mid- and high-dose AMR-001 vs. placebo). There were no deaths in the AMR-001 treatment arm at a median follow-up of 18 months vs. 3 deaths in the placebo arm. Data were presented at the American College of Cardiology meeting in San Diego. ...