"We are encouraged by these results, as BL-1040 is the first injectable liquid polymer being developed to provide mechanical support to damaged heart tissues following MI. The data so far have shown that this therapy may increase cardiac performance or contractility and prevent further damage," stated Professor Leor.
"We believe there is a great unmet medical need for this product to prevent cardiac tissue damage in the risky period following heart attack," commented Morris C. Laster, MD, CEO of BioLineRx. "We look forward to advancing BL-1040 to Phase I/II trials in the second quarter of 2007 and plan to work closely with the U.S. FDA medical devices division to determine the clinical plan for BL-1040."
The data presented at the CRT conference comprised a study in 21 pigs that underwent an acute MI, and then received an intra-coronary administration of BL-1040. The results showed that BL-1040 attenuated infarct expansion and prevented left ventricle dilatation. The intracoronary administration of BL-1040 was feasible and safe, without causing arrhythmias, toxic effects or vascular obstruction.
BL-1040 is a biodegradable liquid polymer intended to provide mechanical support to damaged heart tissue and increase cardiac output. BL-1040 is admin istered via the coronary artery, as a liquid that is injected during catheterization into the damaged heart muscle. The liquid polymerizes within the tissue and forms a protective scaffold that enhances the mechanical strength of the heart muscle during recovery and repair thereby preventing pathological enlargement of the left ventricle after the heart attack. BL-1040 degrades naturally six weeks after injection.
Patients who have undergone an acute MI (AMI) with severe heart damage are the most likely to benefit from BL-1040. Approximately 40% of AMI patients develop left ventricle dilatation or heart failure, which carries a substantially greater mortality risk. This population includes approximately 380,000 patients in the U.S., with a total estimated U.S. market of over $1.5 billion.
BL-1040 was in-licensed from Ben-Gurion University through its business company BGN Technologies, and was developed by Professor Smadar Cohen and Professor Jonathan Leor from the Department of Biotech and Biomedical Engineering at Ben-Gurion University.
BioLineRx, a clinical stage drug development company traded on the Tel Aviv Stock Exchange (BLRX), is dedicated to building a robust pipeline of promising therapeutics for unmet medical needs. The Company's current product pipeline consists of 10 compounds, 3 of which are in or impending clinical trials. Its lead product, BL-1020, for the treatment of schizophrenia, successfully completed Phase 1 clinical trials; and BL-1040, for the treatment of damaged heart tissue post myocardial infarction, is expected to enter the clinic in the second quarter of 2007. Additional products under development include compounds for the treatment of cancer and CNS, cardiovascular, metabolic, infectious and autoimmune diseases.
BioLineRx advances projects from early stage discovery and lead generation to advanced clinical trials, regulatory approval and marketing. Partnering with researchers, universi ties and biotech companies to further the commercialization of promising compounds, BioLineRx seeks to enrich the pipeline of large pharmaceutical companies seeking their next blockbuster drugs. The Company was founded in 2003 by leaders in the Israeli life science arena including Teva Pharmaceuticals Ltd, Giza, Pitango, Hadasit and the Jerusalem Development Authority. For more information, please visit www.biolinerx.com.
Yuri Shoshan, +972-2-548-9100
VP Finance and Corporate Development
Media Liaison, BioLineRx Ltd.
Tsipi Haitovsky, +972-52-598-9892
Stern Investor Relations, Inc.
Melanie Friedman, 212-362-1200