The BioLineRx Drug Development Company Seeks to Begin Clinical Trials of an Implant Developed at Sheba to Treat Damaged Heart Tissue
The Implant Was Developed by Prof. Jonathan Leor of Sheba
together with Prof. Smadar Cohen of Ben Gurion University
BioLineRx Ltd. (TASE:BLRX), Israel's leading drug development company, announced today that it has submitted a request to a European regulatory agency to begin pilot (Phase 1/2) clinical trials of BL-1040, an absorbable implant to treat cardiac tissue damaged as the result of an acute myocardial infarction (heart attack or MI). The submission comes following BioLineRx's successful completion of pre-clinical studies of BL-1040.
The multi-center, open label study will be conducted at several sites in selected European countries and Israel. The results of the study will provide feasibility data that the Company will use to support the pivotal clinical trial that is intended to form the basis of the pre-market approval application for BL-1040 with the U.S. Food and Drug administration (FDA). BioLineRx's development strategy for BL-1040 is the result of extensive discussions with regulatory authorities including a pre-IDE meeting with the FDA in March, 2007.
The safety biocompatibility and efficacy of BL-1040 was demonstrated in pre-clinical trials performed in multiple species. BL-1040 was shown to be safe, improve survival and effective in preventing deterioration of the myocardium, by reducing left ventricle dilatation and eventual heart failure.
"BL-1040 is the first treatment that attempts to treat damaged cardiac tissue resulting from an acute MI and addresses a tremendous unmet medical need. More than one million patients suffer an acute MI each year in the U.S. alone," commented Morris C. Laster, MD, CEO of BioLineRx. "Our regulatory strategy is specifically designed to allow patients to benefit from the technology with an accelerated timeline."
"BL-1040 promises to revolutionize the treatment of patients recovering from massive heart attack," says Professor Jonathan Leor, Director of the Neufeld Cardiac Research Institute at Sheba Medical Center and Tel-Aviv University who together with Professor Smadar Cohen from Ben Gurion University invented and conducted the initial experiments with BL-1040. "I am optimistic that future clinical studies will continue to provide more evidence for the success of our new approach and will bring effective and safe treatment for those patients with injured hearts," added Professor Leor.
BL-1040 is an absorbable liquid polymer intended to provide mechanical support to damaged heart tissue post acute myocardial infarction in order improve cardiac function and survival. BL-1040 is administered via the coronary artery, as a liquid that is injected during catheterization into the blood stream and flows into the damaged heart muscle. The liquid polymerizes within the infarcted 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 MI. BL-1040 is absorbed naturally six weeks after injection leaving behind a stronger, more stable, healthier heart muscle.
Patients who have undergone an acute MI with severe heart damage are the most likely to benefit from BL-1040. Approximately 40% of acute MI patients develop left ventricle dilatation or heart failure, which carries a substantially greater mortality risk. This population includes approximately 380,000 patients in the US, with a total estimated U.S. market of over $1.5 billion.
BioLineRx, a clinical stage drug development company traded on the Tel Aviv Stock Exchange (TASE:BLRX), is dedicated to building a robust pipeline of promising therapeutics for unmet medical needs. The Company's leading programs are for schizophrenia and treatment of damaged heart tissue post-myocardial infarction. 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, universities 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.
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