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Amorcyte Cardiac Cell Therapy Trial Completes Second of Four Phases

Posted on: Tuesday, 8 May 2007, 15:00 CDT

Amorcyte, Inc. (Amorcyte), a privately funded biotechnology company developing cell therapy products to treat cardiovascular disease, announced today the completion of the second of four dose cohorts in its phase I clinical trial.

The trial will now await review of the data by the data safety monitoring board (DSMB) in accordance with the protocol.

"All treatment patients in the second cohort received intra-coronary artery infusion of a specified number of stem cells. The DSMB will review the data on this second treatment group and determine whether to give approval to start accruing patients in the next cohort at an increased pre-specified number of stem cells infused," said Dr. Thomas Moss, Amorcyte's Chief Medical Officer.

Amorcyte's Chairman of the Board, Dr. Andrew L. Pecora, commented on the progress of Amorcyte's clinical trial. "As we close this second cohort of this study, we are pleased to have three clinical centers accruing patients under the direction of investigators with unparalleled reputation in the field. Texas Heart Institute, Vanderbilt University School of Medicine, and Emory University School of Medicine are some of the premier cardiac centers in the United States with exceptional international reputations. With these three sites fully accruing, we expect the final two cohorts of this phase I trial to close quickly once it is approved to proceed."

The Phase I trial initially opened in June at the Emory University School of Medicine in Atlanta, Georgia under Principal Investigator, Arshed A. Quyyumi, MD, FRCP, FACC. The second and third sites to join were Vanderbilt University School of Medicine under Douglas E. Vaughan, MD, FACC, Chief, Division of Cardiovascular Medicine, and Texas Heart Institute at St. Luke's Episcopal Hospital with co-principal investigators Emerson C. Perin, MD, PhD, Director, New Cardiovascular Interventional Technology and James T. Willerson, M.D., president of the UT Health Science Center at Houston, and president-elect and medical director of the Texas Heart Institute.

Amorcyte is actively recruiting patients for the trial and expects patient accrual for its 40-patient Phase I clinical trial to be completed in mid-2007.

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, Inc is a therapeutics company pursuing cell-based therapies for cardiovascular diseases, reimbursable on a commercial scale for widespread clinical use. Amorcyte was incorporated in May 2005 and received approval to open its Phase I trial in September 2005. For more information, visit www.amorcyte.com.

Source: Business Wire

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