Ikaria has commenced its global PRESERVATION I clinical trial for the Bioabsorbable Cardiac Matrix (BCM). BCM, also known as IK-5001, is being investigated to prevent ventricular remodeling and subsequent congestive heart failure following acute myocardial infarction.
This placebo-controlled, multicentre, randomised double-blind clinical trial will involve approximately 300 patients which evaluates the safety and effectiveness of BCM when administered to patients who had successful percutaneous coronary intervention following acute ST-segment elevation myocardial infarction (STEMI).
The Bioabsorbable Cardiac Matrix, an aqueous mixture of sodium alginate and calcium gluconate, will be delivered in a bolus injection via the coronary artery during catheterisation and flows into the damaged heart muscle, where it forms a flexible scaffold, or “matrix”, that provides physical support of the heart muscle during recovery and repair. Once the heart tissue heals, BCM gradually dissipates and is excreted through the kidneys.
“Due to the novel self-assembling and self-disassembling nature of BCM, as well as the fact that it provides structural support to the heart without any metabolic affect on the body, we believe the medical device pathway is the most appropriate regulatory approval pathway,” said Douglas Greene, executive vice president of Research & Development of Ikaria.
It is estimated that of the more than approximately 690,000 patients throughout Europe, Australia and Israel who are hospitalised for acute myocardial infarction, approximately 40% experience the more serious STEMI. According to published estimates, approximately 30% to 40% of patients with acute myocardial infarction later suffer from congestive heart failure. Moreover, the cost of re-hospitalisation and other long-term treatments for congestive heart failure can be significant. The American Heart Association estimates that in 2008 the direct and indirect cost of congestive heart failure was US$20 billion to US$30 billion, of which approximately half was related to acute myocardial infarction.
The major endpoints for the PRESERVATION I trial are:
1) Left ventricular end diastolic volume index (anatomic measurement of left ventricular end diastolic volume index will be assessed through echocardiogram);
2) a validated, disease-specific, self-administered, questionnaire to quantify symptoms, function, and the quality-of-life of subjects, and;
3) an exercise tolerance test to measure the response to treatment in subjects with moderate to severe heart disease.
The CE mark registration of the trial has commenced in Australia, and will be followed in Europe. The trial also is expected to commence in other countries, including Israel.