Date: 2015-07-27
Type of information: Results
phase: 3
Announcement: results
Company: BioLineRx (Israel)
Product: Bioabsorbable Cardiac Matrix BCM (BL-1040)
Action
mechanism: BCM (BL-1040) is a medical device, injected to patients following acute myocardial infarction, intended for prevention of ventricular remodeling and subsequent congestive heart failure. BCM 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. BCM degrades within several weeks of injection and is excreted through the kidneys. Pre-clinical studies in various animal models have demonstrated BCM’s safety and efficacy in preventing cardiac wall thinning and preserving cardiac function. BioLineRx successfully completed a Phase 1/2 pilot clinical trial in 2010 which examined the safety and feasibility of treating patients with BCM following acute myocardial infarction. BL-1040 was licensed to Bellerophon, then known as Ikaria, in 2009. Prior to partnering the project, BioLineRx invested slightly over $10 million in the development of BL-1040. To date, BioLineRx has received a total of $17 million for this asset under the license agreement.
Disease: prevention of cardiac remodeling following an acute myocardial infarction (AMI)
Therapeutic area: Cardiovascular diseases
Country: Australia, Belgium, Canada, France, Germany, Israel, Poland, Spain, USA
Trial
details: PRESERVATION I stands for A Placebo Controlled, Multicenter, Randomized, Double-Blind Trial to Evaluate the Safety and Effectiveness of IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction. The study aims to evaluate the safety and effectiveness of BCM (BL-1040) for prevention of ventricular remodeling and congestive heart failure when administered following AMI. The BCM device is administered to subjects who had successful percutaneous coronary intervention with stent placement after ST-segment elevation myocardial infarction (STEMI) and they will then be monitored for six months. The trial is a placebo-controlled, randomized, double-blind, multi-country and multi-center trial. Three hundred and three AMI patients were enrolled and treated at almost 90 sites worldwide, 16 of which are in the U.S. The study, which includes a six-month follow-up period, is anticipated to be completed in mid-2015. (NCT01226563)
Latest
news: * On July 27, 2015, BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced that its partner, Bellerophon, reported top-line results from its PRESERVATION I clinical trial for Bioabsorbable Cardiac Matrix (BCM). BCM, also known as BioLineRx’s BL-1040, is an investigational, implantable medical device being studied for the prevention of heart failure following an acute myocardial infarction (AMI), commonly known as a heart attack. The 303-patient, randomized, double-blinded, placebo-controlled study showed no statistically significant difference between patients treated with BCM versus placebo for both the primary and the secondary endpoints. PRESERVATION I evaluated the safety and effectiveness of BCM for the prevention of ventricular remodeling and heart failure when administered to subjects who had successful PCI with stent placement after ST-Elevation Myocardial Infarction (STEMI). In the study, subjects were randomized to receive BCM (active treatment) or saline control (placebo treatment) in a 2:1 ratio, two to five days following the initial PCI. The primary endpoint for PRESERVATION I was the change in Left Ventricular End Diastolic Volume Index (LVEDVI) at six months compared to baseline. LVEDVI is an anatomical measurement of ventricular remodeling that was measured by 3-D and 2-D echocardiography. The secondary endpoints for PRESERVATION I were the Kansas City Cardiomyopathy Questionnaire (KCCQ) (summary score); six-minute walk test (6MWT); New York Heart Association (NYHA) functional classification (physician reported); time to cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations adjudicated by a Clinical Events Committee; and time to first re-hospitalization due to any cardiovascular event. Safety was evaluated based on adjudication of cardiac serious adverse events by an independent Clinical Events Committee (CEC), as well as periodic reviews conducted by an independent Data Monitoring Committee (DMC). * On January 14, 2015, BioLineRx announced that patient enrollment has been completed in Bellerophon’s PRESERVATION I pivotal CE Mark registration trial of BL-1040, currently named Bioabsorbable Cardiac Matrix (BCM), a novel resorbable polymer solution for the prevention of cardiac remodeling following an acute myocardial infarction (AMI). Completion of the trial is expected in mid-2015. * On October 31, 2014, BioLineRx announced publication of the results of a previous Phase 1/2 (pilot) study for IK-5001 (BL-1040), currently named Bioabsorbable Cardiac Matrix (BCM). This first-in-man pilot study, which was completed in 2010,demonstrates that intracoronary deployment of BCM is feasible and well tolerated. The study, which was now published in the journal Circulation: Cardiovascular Interventions, was conducted by BioLineRx, and was performed at selected sites in Germany and in Belgium. Twenty seven AMI patients were enrolled and treated with BCM within seven days after the infarction. Clinical safety assessment, including coronary angiography, holter monitoring and blood tests, shows that BCM deployment was well tolerated following the coronary injection, and patient evaluation at six months after treatment confirmed the sustained safety profile of the product. In addition, echocardiography six months after treatment showed preservation of left ventricular functional indices in study participants, implying that BCM has potential to help in preventing cardiac remodeling of the left ventricle. This data is limited due to the uncontrolled nature of the study, but is encouraging in its resemblance to results observed in former pre-clinical studies. BCM, which was out-licensed to Bellerophon in 2009 for further development and commercialization, is in the midst of the PRESERVATION I study, a CE Mark registration trial at over 80 sites worldwide, 16 of which are in the U.S. To date, over 280 patients have been enrolled in the study, which is designed to enroll a total of approximately 300 patients. Enrollment is expected to be completed by the end of this year, with study completion anticipated in mid-2015. * On January 3, 2011, BioLineRx announced the commencement of the PRESERVATION I clinical trial, a CE Mark registration trial of BCM (BL-1040), a novel medical device intended for the prevention of cardiac remodeling following an acute myocardial infarction (AMI). The trial has commenced in Australia, will be followed in Europe, and is expected to commence in additional countries, including Israel. Ikaria Inc., which acquired the license for continuation of development and commercialization of BL-1040 from BioLineRx in July 2009, is now leading BL-1040's clinical development as Bioabsorbable Cardiac Matrix (BCM), previously named IK-5001. Dr. Kinneret Savitsky, CEO of BioLineRx, said, "We are excited to announce the beginning of this pivotal trial for European registration of BL-1040/BCM, a unique product for prevention of pathological cardiac remodeling following AMI. Our strategic partner, Ikaria, who is leading the development of BL-1040/BCM, is making intensive efforts to swiftly develop this breakthrough device and we are confident that their experienced team will carry out the trial to the highest professional standards. We look forward to the results of the PRESERVATION I trial during 2013."
