BioLineRx Ltd. has 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.
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.
“While we share in Bellerophon’s disappointment with the BCM results, we believe BioLineRx’s true value remains in our ability to advance our deep in-house pipeline of mid-late stage assets, including future programs under our strategic collaboration with Novartis, and in particular, our expanding BL-8040 oncology platform,” said Dr. Kinneret Savitsky, CEO of BioLineRx.
Dr. Savitsky continued, “We are on track to report top-line data from our Phase 2 clinical study of BL-8040 for treating relapsed/refractory AML in Q4 2015. Results from the dose escalation phase of this study demonstrated potential best-in-class mobilization of cancer cells from the bone marrow, as well as significant induction of cancer cell death. Additionally, we reported positive safety and efficacy results from a Phase 1 study for BL-8040 as a novel stem cell mobilization treatment for transplantation. We expect to meet with the FDA in order to discuss our next steps in the clinical development program for this indication, including the design of a planned follow-up Phase 2 study. We are also in preparations to initiate three additional Phase 2 studies for BL-8040 in consolidation AML, in AML patients with the FLT3-ITD mutation, and for hypoplastic myelodysplastic syndrome and aplastic anemia. We eagerly anticipate reaching several key inflection points for our BL-8040 platform over the next 12 months, which we hope will add significant value for BioLineRx and our shareholders.”
Dr. Savitsky continued, “We remain well capitalized to achieve our corporate and clinical goals through 2018. So while today’s news is unfortunate, we believe it has minimal impact on our business as a whole and our plans going forward. We look forward to Bellerophon presenting the full study data at the upcoming European Society of Cardiology’s annual meeting and to providing the next steps for this program.”