BioLineRx Announces Publication of Results from Previous Phase 1/2 Trial o f BL-1040; Expecting Study Completion Mid '15

BioLineRx Ltd. (NASDAQ: BLRX), a clinical-stage biopharmaceuticalcompany dedicated to identifying, in-licensing and developing promisingtherapeutic candidates, announced today publication of the results of aprevious Phase 1/2 (pilot) study for IK-5001 (BL-1040), currently namedBioabsorbable Cardiac Matrix (BCM), a novel resorbable polymer solution forthe prevention of cardiac remodeling following an acute myocardial infarction(AMI). This first-in-man pilot study, which was completed in 2010,demonstrates that intracoronary deployment of BCM is feasible and welltolerated.The study, which was now published in the journal Circulation: CardiovascularInterventions, was conducted by BioLineRx, and was performed at selected sitesin Germany and in Belgium. Twenty seven AMI patients were enrolled and treatedwith BCM within seven days after the infarction. Clinical safety assessment,including coronary angiography, holter monitoring and blood tests, shows thatBCM deployment was well tolerated following the coronary injection, andpatient evaluation at six months after treatment confirmed the sustainedsafety profile of the product. In addition, echocardiography six months aftertreatment showed preservation of left ventricular functional indices in studyparticipants, implying that BCM has potential to help in preventing cardiacremodeling of the left ventricle. This data is limited due to the uncontrollednature of the study, but is encouraging in its resemblance to results observedin former pre-clinical studies.BCM, which was out-licensed to Bellerophon in 2009 for further development andcommercialization, is in the midst of the PRESERVATION I study, a CE Markregistration trial at over 80 sites worldwide, 16 of which are in the U.S. Todate, over 280 patients have been enrolled in the study, which is designed toenroll a total of approximately 300 patients. Enrollment is expected to becompleted by the end of this year, with study completion anticipated inmid-2015."We are pleased that the results of this Phase 1/2 trial have been publishedin a highly respected peer journal, since these results were the basis forinitiation of the multicenter, randomized and controlled PRESERVATION I CEMark registration trial to confirm the safety and efficacy of this newapproach in high-risk AMI patients," said Dr. Kinneret Savitsky, BioLineRx'sCEO. "1.5 million cases of myocardial infarction occur annually in the U.S.alone, many of which result in irreversible pathological cardiac remodeling.Pre-clinical studies show that BL-1040 is efficacious at preventing cardiacremodeling following an acute myocardial infarction. The pre-clinical studies,along with certain encouraging trend data in the Phase 1/2 study, raise thehope that we will be able to help preserve cardiac function for millions ofpotential patients around the world. We are eagerly awaiting completion of thePRESERVATION I trial being carried out by our partner Bellerophon, which isexpected in mid-2015.”