Israeli Biopharma outfit, BioLineRx Ltd., has reported a set of unspectacular results from a placebo controlled study, pertaining to the Bioabsorbable Cardiac Matrix(BCM) stent used following Acute Myocardial Infarction (AMI).
BioLineRx’s partner company, Bellerophon, has reported that top-line results from its PRESERVATION I 303-patient, randomized, double-blinded, placebo-controlled study for BCM (also known as BioLineRx’s BL-1040) showed no statistically significant difference between patients treated with BCM versus placebo for both the primary and the secondary endpoints.
So what’s at stake here? Well, the press release tells us more: 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.
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.
“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.
“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.”
Source: Business Wire