I admit this sounds a little farfetched, but its a fascinating approach, so anyway...
BioLineRx Submits Application to Begin Pilot (Phase 1/2) Clinical Trials of BL-1040 to Treat Damaged Cardiac Tissue Following Acute MI
Wednesday June 6, 9:00 am ET
Company Successfully Completes Pre-Clinical Studies
JERUSALEM--(BUSINESS WIRE)--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.
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