Based on the success of the prior Phase I trial, a Phase II trial began enrolling patients in January 2012. The Phase II trial will include 160 patients (80 Treatment and 80 Control) in 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 products.