BioLineRx has begun a CE Mark registration trial, Preservation I, of Bioabsorbable Cardiac Matrix (BCM, BL-1040), a novel medical device designed to prevent cardiac remodelling following an acute myocardial infarction (AMI).
BL-1040 is a medical device, injected into patients via the coronary artery during catheterisation and flowing into the damaged heart muscle generating a scaffold within injured cardiac muscle, improving cardiac mechanical strength during the healing period and preventing pathological ventricular dilation.
The Preservation I trial is a placebo-controlled multicentre randomised double-blind trial intended to evaluate the safety and efficacy of BL-1040 for prevention of ventricular remodelling and congestive heart failure when administered following AMI. The trial included around 300 patients, initially in Australia, followed by Europe, and is also anticipated to commence in additional countries, including Israel. In the study, the BCM device is administered to subjects who had successful percutaneous coronary intervention with stent placement after ST-segment elevation myocardial infarction (STEMI) who are then be monitored for six months.
In July 2009, Ikaria has acquired the licence for continuation of development and commercialisation of BL-1040, previously known as IK-5001, from BioLineRx. BioLineRx CEO Kinneret Savitsky said they are excited to initiate the pivotal trial for European registration of BL-1040/BCM, and they look forward to the results of the Preservation I trial during 2013.
''Our strategic partner, Ikaria, who is leading the development of BL-1040/BCM, is making intensive efforts to swiftly develop this breakthrough device and we are confident that their experienced team will carry out the trial to the highest professional standards,'' she added.
The pre-clinical studies in various animal models have demonstrated BL-1040's safety and efficacy in preventing cardiac wall thinning and preserving cardiac function. Earlier Phase I/II clinical trial also examined the safety and feasibility of treating patients with BL-1040 following acute myocardial infarction.