BL-1040 (Out-Licensed to Bellerophon Therapeutics)
Indication: Acute Myocardial Infarction
Mode of Action: Temporary mechanical support
Stage of development: CE Mark registration trial
Patent status: Patents granted or pending worldwide, 20-year expiration in 2029 (in US); 2024 (rest of world)
BL-1040 Overview
BL-1040 represents a breakthrough approach to supporting cardiac tissue damaged as the result of ischemia. The liquid BL-1040 is administered via intra-coronary injection and, on contact with damaged cardiac tissue, undergoes a transition from liquid to gel. This gel provides mechanical support allowing the damaged tissue to heal as a more compact, less dilated and "tighter" scar, which results in improved long-term cardiac function. BL-1040 resorbs naturally and is excreted from the body within six weeks of injection.
BL-1040 Clinical Data
BioLineRx has completed a phase I/II pilot clinical trial designed to assess the safety and feasibility of BL-1040 in patients who have experienced a significant AMI. The trial was conducted at 9 sites in Europe. An Independent Safety Monitoring Board (ISMB) reviewed the data from the study and concluded that the treatment is safe and clinical development of the device may continue.
BL-1040 (now called "Bioabsorbable Cardiac Matrix” or "BCM” by Bellerophon) is currently undergoing the PRESERVATION I clinical trial, which aims to evaluate the safety and effectiveness of BL-1040 in the prevention of ventricular remodeling and congestive heart failure when administered following AMI. This trial is a double-blind, placebo-controlled, CE Mark registration trial in up to 306 patients following AMI at over 80 sites in nine countries, and includes a six-month follow-up period.
Pre-Clinical Data
BL-1040 efficacy has been extensively studied in different models. The results of these studies show that BL-1040, administered at up to 7 days post AMI, improves survival, prevents the dilation of left ventricular end systolic and diastolic volume, prevents fractional shortening deterioration and improves mitral regurgitation. Treatment also minimizes the systolic wall thinning, a finding consistent with the prevention of progressive infarct expansion.
Safety and biocompatibility studies revealed no evidence of local or systemic toxicity at equivalent, and significant, multiples of the anticipated human dosage.
In July 2009, BioLine out-licensed BL-1040 to Bellerophon (f/k/a Ikaria) for continuation of development and commercialization (under the name IK-5001 and/or BCM).
BL-1040 was invented by Prof. Smadar Cohen and Prof. Jonathan Leor. BL-1040 is being developed by BioLineRx Ltd. under a worldwide exclusive license from B.G. Negev Technologies.
For more information: bd@BioLineRx.com
