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Biopharmaceuticals Regenerative Medicine Cardiology

 News Release - October 23, 2006

Caritas St. Elizabeth's Medical Center's Study Finds Injecting Patient's Own Stem Cells into the Heart to Treat Severe Coronary Artery Disease is Well Tolerated

Study data help establish larger, Phase II trial; Dr. Douglas Losordo to present data at TCT 2006

BOSTON, Oct. 23 (HSMN NewsFeed) -- Encouraging 12-month results from a Phase I trial investigating the injection of adult, autologous CD34+ stem cells into the hearts of patients with severe coronary artery disease will be presented for the first time at the Cardiovascular Research Foundation's (CRF) eighteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C. The data provide evidence that this therapy is well tolerated at this stage and that larger, Phase II clinical trials can continue in humans.

Douglas Losordo, MD, chief of cardiovascular research at Caritas St. Elizabeth's Medical Center, a major academic medical center affiliated with Tufts University School of Medicine, is the principal investigator of the Phase I trial investigating this therapy that involves injecting patients with severe coronary artery disease with a protein that helps to release stem cells from the patient's own bone marrow into the blood stream. These autologous stem cells are gathered, selected and then injected into areas of the heart that have been damaged due to an insufficient supply of oxygen-rich blood.

Data from this randomized, multi-center, placebo-controlled, double-blind trial indicate that the therapy appears to be well-tolerated as no serious adverse events directly related to the stem cell therapy were observed.

Twenty-four patients were enrolled at three centers in the United States from December 2003 through March 2005. There were five females and 19 males with a mean age of 63. Through the duration of the study, there were no deaths or heart attacks. Fifteen of the 18 total Phase I study subjects who received the cells reported feeling better with reductions in chest pain and/or improved exercise capacity. Though not sufficiently powered to prove efficacy, these results did lead the way to the initiation of a randomized, multi-center, placebo-controlled, double-blind Phase II trial, sponsored by the Cellular Therapies business unit of Baxter Healthcare Corporation, in a larger (150 patient) study population.

The American Heart Association estimates that every year, between 125,000 and 250,000 individuals with coronary artery disease develop chronic myocardial ischemia (CMI), one of the most severe forms of coronary artery disease, which can cause unstable angina, heart attacks and progressive heart failure when adequate blood flow is not restored. While cardiologists can restore blood flow in some cases, the heart muscle can be irreversibly damaged, leading to significant disability, progressive heart failure and often death.

"Heart disease is the number one killer of adults in this country, and yet, as clinicians, we are unable to adequately treat many patients with the severest forms of the disease," said Losordo. "The Phase I results demonstrated that patients suffering from severe coronary artery disease who receive injections of their own stem cells can tolerate this treatment. By moving forward with the Phase II trial, we have reached a milestone in exploring further a much-needed therapy for this patient population."

Losordo's presentation will take place at TCT 2006 on Monday, October 23, 2006 at 11:00 am EDT. The Featured Lecture session will be held in Room 147AB of the Washington Convention Center and is titled "First Report of the 1-Year Results of a Double-Blind, Placebo-Controlled, Randomized Trial of CD34+ Cells for Intractable Myocardial Ischemia."

Caritas St. Elizabeth's Medical Center is a major academic medical center affiliated with Tufts University School of Medicine. Areas of medical excellence include cardiology and cardiovascular research, neurosciences, women's health, high-risk obstetrics, bone and joint health, hematology/oncology, pulmonary medicine and gastroenterology. Caritas St. Elizabeth's is a member of Caritas Christi Health Care, the second largest health care system in New England.

Source: Caritas St. Elizabeth's Medical Center

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