NIH awards funding to biotech firm for heart disease

04/25/05

Arteriocyte is first company spun out from Center for Stem Center and Regenerative Medicine

Arteriocyte, the first spin-out company from the Center for Stem Cell and Regenerative Medicine, has received the first installment of its combined Phase I/II "fast track" Small Business Technology Transfer Award grant from the National Heart, Lung, and Blood Institute (NHLBI), one of the components of the National Institutes of Health (NIH). The first installment of the combined $1.4 million grant is for the first phase of a 10 patient study to test the safety of using stem cells to repair ischemic heart tissue caused by an inadequate blood supply to the heart. The balance of the funding from the NHLBI is expected to be awarded later this year, contingent on successful completion of the Phase I study.

Arteriocyte is a start-up company spun out in 2004 from Case Western Reserve University and University Hospitals of Cleveland. It was founded by Mary Laughlin, M.D., and Vincent Pompili, M.D., of University Hospitals of Cleveland and Case Western Reserve University School of Medicine, with assistance from Case's Technology Transfer Office.

Arteriocyte's therapeutic goal is generating new blood vessels ("neovasculogenesis") to replace or supplement those blood vessels that fail to adequately supply oxygenated blood to heart tissue in patients with heart disease. The firm's technology consists of a method for combining multiple stem cell types derived from the blood in a unique way, and then infusing damaged tissues with them so new blood vessels will grow.

Plans call for patient testing to occur at University Hospitals of Cleveland later this year, pending NIH and FDA approval. In the study, patients with blocked or damaged heart vessels will have stem cells drawn from their own blood. These cells will then be enriched in the laboratory and reinjected into the patients at the site of their damaged heart tissue. Researchers expect this procedure to trigger the growth of new blood vessels to replace damaged ones. The therapy has the potential to augment conventional therapies such as artery bypass grafting and angioplasty. Ateriocyte's unique combination of blood cell types has shown encouraging results in animal studies.

Laughlin is director of the Allogeneic Transplant Program at University Hospitals of Cleveland and associate professor of medicine and pathology at Case Western Reserve University. Pompili is director of Interventional Cardiology at University Hospitals of Cleveland and associate professor of medicine and director of coronary care services at Case Western Reserve University. The company is based on technologies developed by the founders and Steven Haynesworth, associate dean of the College of Arts and Sciences at Case. Don Brown, a former executive of Viacell and Schering-Plough, is the company's chief executive officer. The university invested $250,000 in Arteriocyte through its Case Technology Ventures fund.

The grant is part of the NIH's Small Business Technology Transfer Award program, which is designed to help the transfer of innovative technologies from an academic setting to the commercial sector and rapidly translate research discoveries made in the laboratory into therapy for patients.

Blocked or damaged blood vessels are a major cause of illness and death around the world. Atherosclerosis, for example, can lead to congestive heart failure and heart attacks. About 5 million people in the U. S. have heart failure and the number is growing. Each year, another 550,000 people are diagnosed for the first time. It contributes to or causes about 300,000 deaths each year. About 1 percent of the U.S. population over the age of 65 is diagnosed with congestive heart failure each year. Existing therapies include drugs, gene therapy, and vascular interventions for relief of arterial obstructions. In 2003, approximately 750,000 coronary artery bypass graft (CABG) surgeries were performed worldwide and approximately 1.8 million balloon angioplasty procedures were performed. While these interventional therapies are now the standard of care, there are still a significant number of people for whom these methods do not work, or who have blockage throughout their bodies.

Laughlin and Pompili are members of the Center for Stem Cell and Regenerative Medicine, a collaboration among Case, University Hospitals of Cleveland and the Cleveland Clinic Foundation. The center was established with the help of $19 million in state funding in 2003.

Eric Cottington, associate vice president for research at Case, stated "Arteriocyte's NIH award is strong validation that the company's technology represents a novel innovation in the treatment of patients with ischemic disease and is another important step in the continued commercialization of this potentially important stem cell therapy."

Stanton Gerson, M.D., director of the center said, "This innovative technology will use stem cells initially to regenerate diseased blood vessels of the heart. In time, other targets will include peripheral vascular disease that disables people with diabetes, the prevention of stroke, and treatment of renal ischemia. The Center for Stem Cell and Regenerative Medicine promised the citizens of Ohio that it would develop new technology and commercialize it. Arteriocyte represents the first installment on that promise."

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