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

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BioLineRx Ltd.
BLRX
, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today publication of the results of a previous Phase 1/2 (pilot) study for IK-5001 (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). This first-in-man pilot study, which was completed in 2010, demonstrates that intracoronary deployment of BCM is feasible and well tolerated. The study, which was now published in the journal Circulation: Cardiovascular Interventions, was conducted by BioLineRx, and was performed at selected sites in Germany and in Belgium. Twenty seven AMI patients were enrolled and treated with BCM within seven days after the infarction. Clinical safety assessment, including coronary angiography, holter monitoring and blood tests, shows that BCM deployment was well tolerated following the coronary injection, and patient evaluation at six months after treatment confirmed the sustained safety profile of the product. In addition, echocardiography six months after treatment showed preservation of left ventricular functional indices in study participants, implying that BCM has potential to help in preventing cardiac remodeling of the left ventricle. This data is limited due to the uncontrolled nature of the study, but is encouraging in its resemblance to results observed in former pre-clinical studies. BCM, which was out-licensed to Bellerophon in 2009 for further development and commercialization, is in the midst of the PRESERVATION I study, a CE Mark registration trial at over 80 sites worldwide, 16 of which are in the U.S. To date, over 280 patients have been enrolled in the study, which is designed to enroll a total of approximately 300 patients. Enrollment is expected to be completed by the end of this year, with study completion anticipated in mid-2015. "We are pleased that the results of this Phase 1/2 trial have been published in a highly respected peer journal, since these results were the basis for initiation of the multicenter, randomized and controlled PRESERVATION I CE Mark registration trial to confirm the safety and efficacy of this new approach in high-risk AMI patients," said Dr. Kinneret Savitsky, BioLineRx's CEO. "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 cardiac remodeling following an acute myocardial infarction. The pre-clinical studies, along with certain encouraging trend data in the Phase 1/2 study, raise the hope that we will be able to help preserve cardiac function for millions of potential patients around the world. We are eagerly awaiting completion of the PRESERVATION I trial being carried out by our partner Bellerophon, which is expected in mid-2015.”
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