Biotherapeutics company Bellerophon Therapeutics, LLC, has completed enrollment of its PRESERVATION I clinical trial of Bioabsorbable Cardiac Matrix (BCM), an investigational implantable medical device being studied for the prevention of congestive heart failure following an acute myocardial infarction (AMI).
Background
BCM is intended to prevent congestive heart failure after a heart attack. It is a liquid medical device that is administered through an injection in the coronary artery leading to the damaged area of the heart after an AMI. The injection is made using the same minimally invasive percutaneous coronary intervention (PCI) procedure commonly used when opening up cardiac blood vessels and placing a stent. Once BCM is deployed, it flows into damaged heart muscle where it forms a gel which acts as a protective meshwork or scaffold within the wall of the heart’s left ventricle. This flexible scaffold provides physical support to the heart wall and prevents further damage while the heart heals after the AMI. BCM is bioabsorbable and eliminated from the body after the heart heals.
PRESERVATION I is a randomized, double-blind, placebo-controlled trial. The purpose of the study is to evaluate the safety and efficacy of BCM for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous coronary intervention (PCI) with stent placement after ST-Elevation Myocardial Infarction (STEMI) heart attack. The primary endpoint is a change in Left Ventricular End Diastolic Volume Index (LVEDVI) at six months compared to baseline. Secondary endpoints include patient-reported assessment of symptoms, function, and quality of life (Kansas City Cardiomyopathy Questionnaire), functional capacity (Six Minute Walk Test), physician-assessed function (New York Heart Association Functional Classification), and cardiovascular events (death, hospitalization, and time to hospitalization).
If the results of this trial are positive, the company expects it would form the basis for its CE marking application. In addition, the company would expect to conduct a second, larger clinical trial to support approval in the United States through the premarket approval (PMA) pathway.
To date the treatment procedure has been completed in 303 patients at almost 90 clinical sites in Australia, Europe, Israel and North America. The company expects to report top line results in mid-2015, following a six month follow up period for all patients.
Source: PR Newswire
