BioLineRx Announces Initiation of CE Mark Registration Trial for BCM (BL-1040)
Product News Jan 06, 2012
The trial has commenced in Australia, will be followed in Europe, and is expected to commence in additional countries, including Israel.
Ikaria Inc., which acquired the license for continuation of development and commercialization of BL-1040 from BioLineRx in July 2009, is now leading BL-1040's clinical development as Bioabsorbable Cardiac Matrix (BCM), previously named IK-5001.
PRESERVATION stands for A Placebo Controlled, Multicenter, Randomized, Double-Blind Trial to Evaluate the Safety and Effectiveness of IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction.
PRESERVATION I aims to evaluate the safety and effectiveness of BCM (BL-1040) for prevention of ventricular remodeling and congestive heart failure when administered following AMI.
The trial is a placebo-controlled, randomized, double-blind, multi-country and multi-center trial including approximately 300 patients which are expected to be recruited across 45 sites. This includes approximately 50 Australian patients at 11 clinical trial sites.
The BCM device will be administered to subjects who had successful percutaneous coronary intervention with stent placement after ST-segment elevation myocardial infarction (STEMI) and they will then be monitored for six months.
Dr. Kinneret Savitsky, CEO of BioLineRx, said, "We are excited to announce the beginning of this pivotal trial for European registration of BL-1040/BCM, a unique product for prevention of pathological cardiac remodeling following AMI. 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. We look forward to the results of the PRESERVATION I trial during 2013."