BioLineRx (NASDAQ:BLRX) (TASE:BLRX), a biopharmaceutical development company, announced today that a Notice of Allowance has been issued by the United States Patent and Trademark Office (USPTO) for a patent application claiming the composition of BL-1040, a novel medical device for prevention of cardiac remodeling following an acute myocardial infarction. This patent, when issued, will be valid until August 2026. Additional patents claiming the BL-1040 composition and its use for the treatment of ventricular remodeling and congestive heart failure due to acute myocardial infarction are granted or pending in Europe, Japan, Canada, Korea, Mexico, Israel, India, China and Australia.
In June 2009, BioLineRx out-licensed BL-1040 to Ikaria Inc. for continuation of development and commercialization of Bioabsorbable Cardiac Matrix, or BCM (previously named IK-5001). In December 2011, Ikaria commenced the PRESERVATION I clinical trial, a CE Mark registration trial for BCM (BL-1040).
"We are very pleased at receiving this notice of allowance from the USPTO for the patent application covering BL-1040/BCM's composition," stated Dr. Kinneret Savitsky, BioLineRx's CEO. "Currently approximately 1.5 million cases of myocardial infarction occur annually in the U.S. alone, many of which result in irreversible pathological cardiac remodeling. BL-1040 has demonstrated efficacy at preventing cardiac remodeling following an acute myocardial infarction in pre-clinical studies, giving new hope to patients around the world. In addition, we are pleased with the intensive efforts being made by Ikaria, our partner in this project, who is carrying out the CE Mark Registration Trial."
About BL-1040 (BCM)BL-1040 is a medical device, intended to be injected to patients following acute myocardial infarction, for prevention of ventricular remodeling and subsequent congestive heart failure. Ventricular remodeling is the structural alteration of the damaged heart muscle that occurs following an acute heart attack. Once this damage occurs, the weakened heart muscle forces the rest of the heart to compensate. Under this extra workload, the heart muscle dilates, the walls of the heart thin, and the heart further remodels, thereby causing another cycle of dilation and overcompensation. The extra workload to the heart causes further structural damage and can lead to congestive heart failure. BL-1040 is a liquid polymer which is delivered in a bolus injection via the coronary artery during catheterization and flows into the damaged heart muscle, creating a scaffold within injured cardiac muscle, designed to enhance cardiac mechanical strength during the healing period and prevent pathological ventricular dilation. BL-1040 degrades within several weeks of injection and is excreted through the kidneys. Pre-clinical studies in various animal models have demonstrated BL-1040’s safety and efficacy in preventing cardiac wall thinning and preserving cardiac function.