Amorcyte, Inc. (Amorcyte), a biopharmaceutical company developing cell therapy products to treat cardiovascular disease, announced that it has been granted United States Patent number 7,794,705 titled "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 US 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.
Claims of this patent, which will remain in effect until at least May 2028, cover Amorcyte's proprietary formulation that maintains the potency of CD34+ stem cells having CXCR-4+ receptors and their ability to migrate quickly after delivery to the vascular injury site, as well as methods of delivering the product through use of a catheter.
"The issuance of this patent is a significant milestone for Amorcyte and provides us with a strong commercial position for our lead product candidate, AMR-001 to treat heart damage after an AMI, as well as other therapeutic indications in treating the consequences of vascular injury," said Andrew L. Pecora, M.D., founder and chairman of the board of Amorcyte. "Understanding how fundamental this patent is to the emerging field of regenerative medicine, it is our desire to enter into appropriate collaborations with other companies whose development efforts complement our approach."
Amorcyte's lead product, AMR-001, is in development for the prevention of major adverse cardiac events following AMI. AMR-001 uses the patients' own enriched bone marrow stem cells as treatment for cardiovascular disease. The process infuses CD34+CXCR-4+ stem cells into the heart a week or so after a heart attack, where they migrate to the site of vascular injury and linger helping to restore damaged tissue. The CD34+ stem cells are enriched using Amorcyte's proprietary technology to assure their potency, purity, sterility and product shelf-life.
Data from a phase I study evaluating AMR-001, reported last year at the scientific session of the American College of Cardiology, demonstrated a significant improvement in perfusion, a trend towards improved cardiac function and the potential to reduce subsequent adverse cardiac events following AMI. This was the first clinical study ever to show a dose-related significant improvement in cardiac perfusion following a severe heart attack.
Amorcyte is pursuing patent rights outside the US and additional patent rights in the US directed to related aspects of its proprietary stem cell technology.
Amorcyte is a privately held biotechnology company developing cell therapy products to treat cardiovascular disease. Its lead product AMR-001, for the prevention of major adverse cardiac events following acute myocardial infarction (AMI), has completed phase I clinical trials demonstrating feasibility, safety and biologic activity at a threshold dose.