AMR–001: A Cell Therapy for Acute Myocardial Infarction
AMR–001 is Amorcyte’s lead product 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. Furthermore, treatment with AMR–001 fits seamlessly into physicians’ standard treatment practices. Administered in the catheterization laboratory as an out-patient procedure, AMR–001 is a simple addition to the standard of care.

Unique Value Proposition:
Preventing Subsequent Adverse Cardiac Events

Amorcyte’s therapeutic strategy focuses on preventing major adverse cardiac events following a severe heart attack (ST-elevation MI resulting in a left ventricular ejection fraction of less than 50%). AMR–001 is being developed for this segment of cardiac patients who are at significant risk for downstream major adverse events including premature death, recurrent myocardial infarction, congestive heart failure, significant arrhythmias, acute coronary syndrome and poor quality of life. These patients represent a large cost segment, and are always the number one burden in any man- aged care program. We expect this burden to increase, despite the impact of statin use, as the baby boomer population ages. AMR–001 is expected to have a significant pharmacoeconomic benefit by preventing downstream events.

Proprietary Technology With a Defined Mechanism of Action

AMR–001 works by increasing microvascular blood flow in the myocardium via neoangiogenesis, thereby reversing post-infarct ischemia and rescuing tissue from hibernation and preventing eventual death (apoptosis):

• CD34+CXCR4+ cells are harvested from the patient’s own bone marrow and isolated to increase potency using Amorcyte’s patented technology
• The selected cells are infused via the infarct–related artery 7–10 days following the ST–Elevation MI (STEMI) – the optimal time frame for cellular intervention, after the pro–inflammatory “hot phase” and prior to permanent scar formation
• The infused CD34+CXCR4+ cells home to the at–risk tissue via the SDF–1 gradient, inducing neoangiogenesis and a resultant functional benefit
• Amorcyte has recently verified the mechanism of action (CD34+CXCR4+ cell induced neoangiogenesis resulting in a functional benefit) of AMR–001 in animal models and in humans in a phase I trial. Publication is in process.