Incorporated in 2005 and headquartered in Allendale, New Jersey, Amorcyte, Inc. is a development stage cellular therapies company focused on developing novel treatments for cardiovascular disease. Currently, the company is developing its first product candidate, AMR–001, which is a bone marrow-derived, CD34 positive selected stem cell product for the treatment of damaged heart muscle following acute myocardial infarction (AMI). The company completed a Phase I clinical trial which raised no safety concerns and established a biological threshold dose with statistical significance in patients who experience a STEMI (heart attack). Specifically, at doses ≥10 million CD34+ cells demonstrating SDF-1 mobility, there was a significant improvement in infarct region perfusion, trend to improvement in LVEF (left ventricular ejection fraction), and lower incidence of decreased LVEF at 6-month follow-up compared with patients in the control group and those receiving 5 million cells.

Amorcyte was spun off from Progenitor Cell Therapy (PCT) in 2006, and, in October 2011  was  acquired by NeoStem as a wholly-owned company, effectively reuniting it with PCT and providing capital to fund the next steps for  its clinical development programs.

Approximately 800,000 events of acute myocardial infarction occur in the US each year with about 20% or approximately 160,000 patients having a ST-Elevation MI (STEMI) resulting in a reduced Left Ventricular Ejection Fraction (LVEF) of less than 50%. In simple terms, the AMI was big enough to  materially damage the heart muscle  and, over time, causes the heart  to fail. These patients are at significant risk of downstream adverse events including congestive heart failure, re-current AMI, significant arrhythmias, premature death or acute coronary syndrome.  These patients represent  the target population for AMR-001 and  an accessible market of over $1.2 billion annually for AMR–001.

Based on the success of the prior Phase I trial, a Phase II trial has begun enrolling patients in January of 2012. The Phase II trial will include 160 patients (80 Treatment and 80 Control) at approximately 34 sites. The company expects participation from leading US research hospitals. We anticipate the Phase II trial will take approximately 12 months to enroll the patients who will be initially followed for 6 months to determine the key study endpoint outcomes  and will continue to be tracked for 3 years post treatment.  

Amorcyte has been granted a United Sates patent entitled "Compositions and Methods of Vascular Injury Repair." The patent contains both composition of matter and method claims surrounding therapeutic chemotactic hematopoietic stem cell products used in treating or repairing a vascular injury following an acute myocardial infarction (AMI), and delivery of the cell therapy. This is the first instance of a U.S. patent being issued for a chemotactic hematopoietic stem cell product, its delivery and the cell potency and stability needed to treat the consequences of a vascular injury. In addition, patent applications are pending in the U.S. and around the world that seek further protections for Amorcyte’s stem cell patents.