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
“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
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
About PRESERVATION I
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
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).
BioLineRx is a publicly-traded, clinical-stage biopharmaceutical company
dedicated to identifying, in-licensing and developing promising
therapeutic candidates. The Company in-licenses novel compounds
primarily from academic institutions and biotech companies based in
BioLineRx’s current portfolio consists of a variety of clinical and pre-clinical projects, including: BL-8040, a cancer therapy platform, which is in the midst of a Phase 2 study for acute myeloid leukemia (AML), and has successfully completed a Phase 1 study in stem cell mobilization; BL-7010 for celiac disease, which has successfully completed a Phase 1/2 study; and BL-1040 for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Bellerophon BCM (f/k/a Ikaria).
In December 2014, BioLineRx entered into a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates. The companies intend to co-develop a number of pre-clinical and early clinical therapeutic projects through clinical proof-of-concept for potential future licensing by Novartis.
For more information on BioLineRx, please visit www.biolinerx.com
or download the investor relations mobile device app, which allows users
access to the Company’s
Various statements in this release concerning BioLineRx’s future expectations constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as “may,” “expects,” “anticipates,” “believes,” and “intends,” and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the “Risk Factors” section of BioLineRx’s most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 23, 2015. In addition, any forward-looking statements represent BioLineRx’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
Strategic Advisors, Inc.
Joshua Drumm, Ph.D., +1-212-375-2664
Andrew Mielach, +1-212-375-2694
Tsipi Haitovsky, +972-3-6240871