NeoStem Phase 2 has begun on AMR-001

AMR–001: A Cell Therapy for Acute Myocardial Infarction — AMR–001 is Amorcyte’s lead product candidate for the treatment of damaged heart muscle following AMI. An autologous bone marrow derived, CD34 positive selected stem cell product, AMR–001 limits the damage of heart muscle that develops following AMI and, thus, has the potential to limit ventricular remodeling. Administered in the catheterization laboratory as an out-patient procedure, AMR–001 is anticipated to become an important addition to the standard of care of post STEMI patients.The Phase II trial has been designed to evaluate the potential of AMR-001 to improve perfusion, preserve cardiac function and improve clinical outcomes. The trial is expected to include 160 patients in a placebo controlled, double-blind study.   A composite of cardiac measures, including clinically meaningful endpoints, will support the primary endpoint of perfusion. In a Phase I study of 31 patients, AMR–001 showed a dose–related significant improvement in perfusion. Presented at the 2009 American College of Cardiology Annual Scientific Session, the Phase I study results demonstrated that patients receiving 10 and 15 million cells (n=9) showed significant improvement in resting perfusion rates at six months as compared to patients receiving 5 million cells (n=6) and control (n=15), as measured by the SPECT total severity score, (–256 versus +13, p=0.01). The data also showed that patients receiving 10 or more million cells showed a trend towards improvement in ejection fraction, the percentage of blood pumped out of a ventricle with each heartbeat, (+4.5% versus +0.69%); end systolic volume (–5.7mL versus +3.5mL); and infarct size, tissue death due to loss of adequate blood supply, (–7.4% versus –5.3%) at six month follow–up. No study–related significant adverse events were