Genzyme Biosurgery, a division of Genzyme Corporation, announced that doctors in Paris have treated the first patient enrolled in a Phase 2 clinical trial testing the safety and effectiveness of cardiac myoblast cell transplantation, an experimental new therapy designed to prevent the progression of heart failure in patients who have had a heart attack.

The Phase 2 clinical trial is being principally funded by Genzyme Biosurgery, with support from Assistance Publique - Hopitaux de Paris. It is being conducted in partnership with Myosix SA of Paris.

Philippe Menasche, principal investigator of the trial, treated the first patient late last week. The results of Dr. Menasche's Phase 1 clinical trial, presented at last month's meeting of the American Heart Association, suggested that myoblast transplantation may help halt or slow the progressive deterioration of heart function that is common among patients with congestive heart failure.

Genzyme Biosurgery's Phase 2 trial employs the same technique as the earlier trial. It involves harvesting a patient's own (autologous) skeletal muscle cells prior to bypass surgery through a small biopsy in the leg, multiplying the cells over the course of three weeks in the laboratory, and injecting them into a scarred region of the heart during a coronary artery bypass operation.

The randomized, double blind, placebo controlled trial will enroll up to 300 patients in as many as 30 medical centers throughout Europe and North America. Cardiac surgeons will administer the myoblast transplant or placebo during bypass surgery. An independent team of cardiologists will conduct blinded assessments of safety and efficacy measures of the treated and placebo groups. Measures to be evaluated include monitoring the area into which the cells were injected to determine whether the engrafted cells restore the heart's ability to contract in that area; changes in left ventricular ejection fraction; and a comparison of the incidence of Major Adverse Cardiac Events (MACE) between treated and non-treated groups. MACE is a commonly used measure of the clinical effectiveness of new therapies in heart failure patients.

All patients eligible for this study will also be qualified to receive an implantable defibrillator for primary prevention of ventricular arrhythmias under the revised 2002 ACC/AHA/NASPE Guideline for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices. At the start of the trial, all patients will be equipped with an implantable cardioverter defibrillator (ICD) to aid in assessing whether the therapy has any effect on cardiac arrhythmia. Monitoring of all patients will continue for up to two years after treatment.

It is anticipated that patients will be enrolled in sites outside of France in Europe, the United States and Canada during the first half of 2003.