BioLineRx Announces Completion of Enrollment in CE Mark Registration Trial of BCM
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BioLineRx Ltd. has announced that patient enrollment has been completed in Bellerophon’s PRESERVATION I pivotal CE Mark registration trial of BL-1040, currently named Bioabsorbable Cardiac Matrix (BCM), a novel resorbable polymer solution for the prevention of cardiac remodeling following an acute myocardial infarction (AMI).
"We are very excited with the successful completion of this important milestone by our partner Bellerophon," said Dr. Kinneret Savitsky, BioLineRx's CEO. "1.9 million cases of myocardial infarction occur annually in the U.S. and the European Union, many of which result in irreversible pathological damage to the heart, termed cardiac remodeling. BCM is aimed at minimizing the development of cardiac remodeling and pre-clinical studies, along with encouraging trend data from the previous Phase 1/2 study, raise the hope that we will be able to help preserve cardiac function of potential patients around the world. We are eagerly awaiting completion of the PRESERVATION I trial, which is expected in mid-2015.”
“In addition, we are very pleased that our previous dispute with Bellerophon has been resolved, as we disclosed earlier today in a Form 6-K submission,” concluded Dr. Savitsky.
The PRESERVATION I CE Mark registration trial is a double-blind, placebo-controlled study aimed at evaluating the safety and effectiveness of BL-1040 in the prevention of ventricular remodeling and congestive heart failure when administered following AMI.
Three hundred and three AMI patients were enrolled and treated at almost 90 sites worldwide, 16 of which are in the U.S. The study, which includes a six-month follow-up period, is anticipated to be completed in mid-2015.