Amorcyte's lead product, AMR-001, is an autologous bone marrow derived stem cell treatment designed to prevent major adverse cardiac events following acute myocardial infarction (AMI). AMR-001 is a pharmaceutical grade product enriched for CD34+CXCR4+ cells. The significance of the product is the following:

·         Homogeneous and Highly purified cell population enriched for CD34+CXCR4+ cells

·         Mechanism of action - targeted homing to preserve cardiomyocytes through angiogenesis and paracrine effects

·         Threshold dose for efficacy established to mitigate biologic variability

·         Infusion in 5-11 days post AMI - the critical time frame for repair

·         Active cell population defined by response to a hypocix environment

The PreSERVE AMI Phase II trial has been designed to evaluate the potential of AMR-001 to improve perfusion, preserve cardiac function and improve clinical outcomes. We intend to enroll 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.

There is ample historical precedent and prior art, data from several published clinical trials with a similar cell population, as well as our own data, demonstrates the potential effectiveness of this cell-based therapy for preserving cardia funtion and preventing the adverse clinicalevents that usually follow a large myocardial infarction. Our Phase I clinical trial of AMR-001 yielded significant results, forming the bases for the Phase II trial.

Dr. Andrew L. Pecora, Chief Medical Officer of NeoStem