Bellerophon closes patient enrolment in Preservation I trial of BCM

15 January 2015 (Last Updated January 15th, 2015 18:30)

Bellerophon Therapeutics has completed patient enrolment in its Preservation I CE Mark registration trial of Bioabsorbable Cardiac Matrix (BCM), an investigational implantable medical device being examined to prevent congestive heart failure following an acute myocardial infarction (AMI).

Bellerophon Therapeutics has completed patient enrolment in its Preservation I CE Mark registration trial of Bioabsorbable Cardiac Matrix (BCM), an investigational implantable medical device being examined to prevent congestive heart failure following an acute myocardial infarction (AMI).

A total of 303 AMI patients were enrolled and treated at nearly 90 clinical sites in Australia, Europe, Israel and North America.

The double-blind, placebo-controlled trial was designed to evaluate safety and effectiveness of BCM in the prevention of ventricular remodeling and congestive heart failure, when administered following AMI.

The trial, which includes a six-month follow-up period for all patients, is expected to be completed in mid-2015.

Each year, more than 1.9 million patients suffer a heart attack in the US and European Union (EU), of which 35%-40% develop congestive heart failure within five years of the event.

"The double-blind, placebo-controlled trial was designed to evaluate safety and effectiveness of BCM in the prevention of ventricular remodeling and congestive heart failure, when administered following AMI."

If the results of the Preservation I trial are positive, the company intends to use it to form the basis for its CE marking application.

In addition, Bellerophon expects to conduct a second, larger clinical trial to support approval in the US through the premarket approval (PMA) pathway.

The trial's primary endpoint is a change in left ventricular end-diastolic volume index (LVEDVI) at six months compared to baseline.

LVEDVI is an anatomic measurement of ventricular remodeling evaluated through an echocardiogram.

Secondary endpoints of the trial include patient-reported evaluation of symptoms, function, quality of life, functional capacity, physician-assessed function, and cardiovascular events.

BCM is a liquid medical device that is administered through an injection, which is made by a minimally invasive procedure called percutaneous coronary intervention (PCI) commonly used when opening up cardiac blood vessels and placing a stent.

Following deployment, BCM flows into the 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.