BioLineRx Announces New Analysis of EAGLE Phase IIb Study Showing a Significantly Greater Beneficial Effect of BL-1020 on

  BioLineRx Announces New Analysis of EAGLE Phase IIb Study Showing a
  Significantly Greater Beneficial Effect of BL-1020 on Cognitive Function in
  Schizophrenia Patients

–BL-1020 is currently undergoing the CLARITY Phase II/III clinical trial with
                         results expected in H2 2013–

Business Wire

JERUSALEM -- October 09, 2012

BioLineRx (NASDAQ: BLRX)(TASE: BLRX), a biopharmaceutical development
company, announced today that a recent analysis of the results from the Phase
IIb EAGLE trial for BL-1020, a first in class, orally available, GABA-enhanced
antipsychotic for the treatment of schizophrenia, indicates that BL-1020
demonstrated a significant increase in efficacy at improving cognitive
impairment associated with this condition, as compared to the original
analysis of the study.

The findings pertain to the results of the Phase IIb EAGLE study, first
published in September 2009, for determining safety, efficacy, and
tolerability of BL-1020 compared to Risperidone, an approved atypical
antipsychotic drug, and placebo. Results of the study showed that BL-1020 was
significantly better than the placebo and comparable with Risperidone in both
PANSS and CGI scores, which are widely recognized measures of severity and
improvement in schizophrenia. In addition, the results showed a statistically
significant improvement in cognitive function as assessed by BACS (Brief
Assessment of Cognition in Schizophrenia), when compared to both placebo and
Risperidone.

Recently, an outside research group performed a further analysis of the
results of the EAGLE study, which specifically take into account effects of
the circadian rhythm (i.e., 24-hour time cycle) on cognitive function of the
subjects. Results of the re-analysis clearly show that when the time of day
for administration of the neurocognitive BACS test was consistent between
visits, the beneficial effect of BL-1020 on cognitive function was even more
pronounced than the original analysis. Specifically, the original analysis for
all patients in the study showed an effect size of 0.40 for BL-1020 versus
placebo and an effect size of 0.39 for BL-1020 versus Risperidone. However,
according to the re-analysis, for the subset of patients with consistent
testing times, the effect size increased significantly, to 0.97 for BL-1020
versus placebo and 0.57 for BL-1020 versus Risperidone. These results mean
that the beneficial effect of BL-1020 on cognitive function, when compared to
the original analysis, more than doubled versus placebo and increased by
almost 50% versus Risperidone.

Dr. Kinneret Savitsky, CEO of BioLineRx, stated,“Cognitive functioning is
influenced by circadian rhythms over the course of the day, and patients with
schizophrenia are known to have profoundly disturbed circadian rhythms that
can affect their cognitive functioning. Therefore, a new analysis was
performed to determine whether taking into account consistency in the timing
of neurocognitive testing between the baseline and endpoint visits could
affect assessment of the efficacy of BL-1020. This analysis found that when
the baseline and endpoint visits were conducted at the same time of day, there
was a significantly more robust treatment response as compared to those
patients where the timing of the visits was inconsistent. These findings
indicate that BL-1020 is even more efficient at improving cognitive function
than was previously shown.”

"We are very excited with these new findings by an outside group of leading
scientists relating to the EAGLE trial. The results not only show an increased
efficacy of BL-1020 in improving cognitive function in schizophrenia patients,
but also have positive implications on conducting and analyzing the ongoing
CLARITY trial, which is specifically designed for assessing BL-1020’s
cognition enhancement effect," concluded Dr. Savitsky.

About BL-1020

BL-1020 is a first-in-class GABA-enhanced antipsychotic that combines dopamine
antagonism with GABAergic activity. BL-1020 has demonstrated high efficacy and
safety with minimal EPS and no metabolic side effects. Most importantly,
BL-1020 may have the potential to improve cognition, which is a significant
unmet medical need in schizophrenia and other neurological/psychiatric
disorders. Three clinical studies have confirmed the safety and efficacy of
BL-1020, while pre-clinical studies have also shown that BL-1020’s GABA
enhancement may provide the basis for improved cognition.

In June 2011, BioLineRx announced commencement of the Phase II/III CLARITY
clinical trial of BL-1020. This 450-patient trial aims to determine the
short-term (6 weeks) and the long-term (24 weeks) cognitive benefit and
anti-psychotic efficacy, safety and tolerability of BL-1020 in schizophrenia
patients, compared with Risperidone (one of the leading schizophrenia
treatments). The CLARITY trial is proceeding at approximately 30 sites in
Romania and India.

About Schizophrenia

Schizophrenia is a serious mental disorder that affects about 1% of the
world’s population. It is a multi-factorial disease characterized by delusions
and hallucinations, emotional withdrawal and apathy, poor attention and
disorganization. The worldwide antipsychotic therapeutic market in 2011 was
estimated at approximately $20 billion.

About BioLineRx

BioLineRx is a publicly-traded biopharmaceutical development company.
BioLineRx is dedicated to building a portfolio of products for unmet medical
needs or with advantages over currently available therapies. BioLineRx’s
current portfolio consists of six clinical stage candidates: BL-1020 for
schizophrenia is currently undergoing a Phase II/III study; BL-1040, for
prevention of pathological cardiac remodeling following a myocardial
infarction, which has been out-licensed to Ikaria Inc., is currently
undergoing a pivotal CE-Mark registration trial; BL-5010 for non-surgical
removal of skin lesions has completed a Phase I/II study; BL-1021 for
neuropathic pain is in Phase I development, BL-7040 for treating inflammatory
bowel disease (IBD) has commenced a Phase II trial, and BL-8040 for treating
acute myeloid leukemia (AML) has completed Phase I. In addition, BioLineRx has
nine products in various pre-clinical development stages for a variety of
indications, including central nervous system diseases, infectious diseases,
cardiovascular and autoimmune diseases.

BioLineRx’s business model is based on acquiring molecules mainly from
biotechnological incubators and academic institutions. The Company performs
feasibility assessment studies and development through pre-clinical and
clinical stages, with partial funding from the Israeli Government’s Office of
the Chief Scientist (OCS). The final stage includes partnering with medium and
large pharmaceutical companies for advanced clinical development (Phase III)
and commercialization. For more information on BioLineRx, please visit
www.biolinerx.com.

Various statements in this release concerning BioLineRx’s future expectations,
including specifically those related to the development and commercialization
of BL-1020, 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 22, 2012. 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.

Contact:

KCSA Strategic Communications
Garth Russell / Todd Fromer
1 212-896-1250 / 1 212-896-1215
grussell@kcsa.com / tfromer@kcsa.com
or
BioLineRx
Tsipi Haitovsky
Public Relations
+972-52-598-9892
tsipih@netvision.net.il
 
Press spacebar to pause and continue. Press esc to stop.