BioLineRx has presented the top-line results from its Preservation I clinical trial of Bioabsorbable Cardiac Matrix (BCM).
BCM, otherwise called as BioLineRx’s BL-1040, is an investigational and implantable medical device being studied to prevent heart failure following an acute myocardial infarction (AMI) or commonly known as a heart attack.
The 303-patient, randomized, double-blinded and placebo-controlled trial demonstrated no statistically significant difference between patients treated with BCM against placebo for both the primary and the secondary endpoints, said BioLineRx.
In 2009, Bellerophon received license for BL-1040 and changed the name to Ikaria.
BioLineRx CEO Dr Kinneret Savitsky said: "We are on track to report top-line data from our Phase II clinical study of BL-8040 for treating relapsed/refractory AML in Q4 2015."
Preservation I trial assessed the safety and effectiveness of BCM to prevent ventricular remodeling and heart failure when administered to subjects who had successful PCI with stent placement after ST-Elevation Myocardial Infarction (STEMI).
In the trial, subjects have been randomized to receive BCM (active treatment) or saline control (placebo treatment) in a 2:1 ratio, two to five days following the initial PCI.
The trials primary endpoint was the change in Left Ventricular End Diastolic Volume Index (LVEDVI) at six months compared to baseline and secondary endpoints were the Kansas City Cardiomyopathy Questionnaire (KCCQ) (summary score), six-minute walk test (6MWT) and New York Heart Association (NYHA) functional classification (physician reported) and others.