BL-1040 (Out-Licensed to Ikaria Inc. )
| Indication: | Acute Myocardial Infarction | |
| Mode of Action: | Temporary mechanical support | |
| Stage of development: | CE Mark Registration Trial; out-licensed to Ikaria Inc. | |
| Patent status: | Patents granted or pending worldwide, 20-years expiration in 2024 (2029 in the USA). |
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 recently 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 in 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 (BCM) is currently undergoing the PRESERVATION I clinical trial, a CE Mark Registration trial.
Pre-Clinical Data
BL-1040 efficacy was extensively studied in the U.S., Europe, and Israel. 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.
BioLineRx has recently 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 in 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 (BCM) is currently undergoing the PRESERVATION I clinical trial, a CE Mark Registration trial.
Pre-Clinical Data
BL-1040 efficacy was extensively studied in the U.S., Europe, and Israel. 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 Ikaria Inc. for continuation of development and commercialization (under the name IK-5001).
BL-1040's first pivotal trial, examining safety and efficacy, is expected to commence in the second half of 2011. This trial aims to evaluate the safety and effectiveness of BL-1040 in the prevention of ventricular remodeling and congestive heart failure when administered following AMI. The trial will be a placebo-controlled, double-blind trial including approximately 270 patients who will be treated with BL-1040 following AMI and will then be monitored for six months. The trial is the first of two partially overlapping pivotal clinical trials to be carried out by Ikaria.
In July 2009, BioLine out-licensed BL-1040 to Ikaria Inc. for continuation of development and commercialization (under the name IK-5001).
BL-1040's first pivotal trial, examining safety and efficacy, is expected to commence in the second half of 2011. This trial aims to evaluate the safety and effectiveness of BL-1040 in the prevention of ventricular remodeling and congestive heart failure when administered following AMI. The trial will be a placebo-controlled, double-blind trial including approximately 270 patients who will be treated with BL-1040 following AMI and will then be monitored for six months. The trial is the first of two partially overlapping pivotal clinical trials to be carried out by Ikaria.
Out licensed to Ikaria Inc.and being developed as Bioabsorbable Cardiac Matrix (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
