Amorcyte, Inc. (Amorcyte) announced the completion of the phase I clinical trial of its lead product, AMR-001 - an autologous stem cell product for the treatment of damaged heart muscle following acute myocardial infarction (AMI).
"All treatment patients in each dose cohort of the phase I trial received intra-coronary artery infusion of a specified number of stem cells. The number of stem cells infused was increased over the previous cohort", said Dr. Thomas Moss, Amorcyte's Chief Medical Officer.
"We are excited to have completed the phase I clinical trial of AMR-001 in patients with acute myocardial infarction (AMI), or heart attack, who have suffered significant damage to their heart muscle," stated Arshed A. Quyyumi, MD, FRCP, FACC, Professor of Medicine, Cardiology, at Emory University School of Medicine and the trial's principal investigator. "This trial has demonstrated proof of principle for this type of cell-based therapy. We have shown that it is possible to take progenitor stem cells harvested and extracted from a patient's bone marrow shortly after a heart attack and deliver these cells back into the patient's heart with the intent of repairing the damaged heart muscle. We eagerly anticipate beginning a phase II trial".
Amorcyte is a company led by experienced management and guided by the outstanding expertise of a Scientific Advisory Board comprised of Bernard J. Gersh, MB ChB, D.Phil, Professor of Medicine at Mayo Clinic of Medicine and Consultant in Cardiovascular Diseases; Dean J. Kereiakes, MD, Medical Director of the Heart Center of Greater Cincinnati at Christ Hospital; Emerson C. Perin, MD, PhD, FACC, Director, New Interventional Cardiovascular Technology, Texas Heart Institute; Arshed A. Quyyumi, MD, FRCP, FACC, Professor of Medicine, Cardiology, Emory University School of Medicine; Edmund Waller, MD, PhD, FACP, Professor of Medicine at Emory Health Care Division of Cardiology; Ned Waller, MD, Professor of Medicine, Hematology and Stem Cell Biology, Emory University School of Medicine; James T. Willerson, MD, President of the University of Texas Health Science Center; and Ching Zhu, PhD, MBA, Partner, PA Early Stage Partners formerly of Guidant Corp.
"We believe that with the guidance of our external advisors, we have an unparalleled clinical trial strategy which, combined with our approach to corporate development, provides an outstanding opportunity for both clinical and commercial success," states Andrew L. Pecora, MD, Amorcyte's Board Chairman. Results form pre-clinical studies were reported at the 2007 American Society of Hematology Meeting. The company anticipates reporting preliminary clinical results later this year.
About Cardiovascular Disease
It is estimated that each year there are approximately 1.1 million instances of acute myocardial infarctions, 12 million cases of chronic ischemia and 5 million occurrences of congestive heart failure in the United States. A significant percentage of these patients may benefit from additional therapies to ameliorate the symptoms of their disease. Therapies like those being developed by Amorcyte are under active investigation to determine safety and efficacy.
About Amorcyte, Inc.
Amorcyte is a privately funded biotechnology company developing cell therapy products to treat cardiovascular disease, reimbursable on a commercial scale for widespread clinical use. Amorcyte has partnered with Progenitor Cell Therapy, a leading cell therapy contract service provider for clinical, manufacturing and other services.
Amorcyte, Inc