Ikaria has started the Preservation I clinical trial for its Bioabsorbable Cardiac Matrix (BCM) also known as IK-5001.
The double-blind, multi-center, placebo-controlled and randomized trial, enrolling upto 300 patients, is designed to assess the safety and effectiveness of IK-5001 when administered to patients who had successful percutaneous coronary intervention (PCI) following acute ST-segment elevation myocardial infarction (STEMI).
The endpoints for the trial include left ventricular end diastolic volume index (anatomic measurement of left ventricular end diastolic volume index will be evaluated through echocardiogram).
A validated, disease-specific, self-administered, questionnaire is used to quantify symptoms, function, and the quality-of-life of subjects and an exercise tolerance test to measure the response to treatment in subjects with moderate to severe heart disease.
BCM is an aqueous mixture of sodium alginate and calcium gluconate.
During catheterization, through a bolus injection via the coronary artery, BCM will be delivered into a damaged heart muscle, where it forms a flexible scaffold, or "matrix," and provides physical support of the heart muscle during recovery and repair and treats congestive heart failure (CHF) .
In 2009, Ikaria has purchased the license to develop and commercialize BioLineRx’s BCM.
Ikaria said the CE Mark registration trial has commenced in Australia and plans to recruit approximately 50 Australian patients and then will be followed in Europe and is also expected to start trial in other countries, including Israel.