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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. (NASDAQ: 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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