BioLineRx to Conduct Interim Analysis of Phase II/III CLARITY Clinical Trial of BL-1020 for Treatment of Schizophrenia

  BioLineRx to Conduct Interim Analysis of Phase II/III CLARITY Clinical Trial
  of BL-1020 for Treatment of Schizophrenia

             – Results of interim analysis expected in Q1 2013 –

Business Wire

JERUSALEM -- October 24, 2012

BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development
company, announced today that it intends to conduct an interim analysis of the
Phase II/III CLARITY trial of BL-1020, a first in class, orally available,
GABA-enhanced antipsychotic for the treatment of schizophrenia. The interim
analysis, which is expected to be finalized in the first quarter of 2013, will
be performed on data of approximately 235 randomized patients from 27 sites in
Romania and India. The primary endpoint of the analysis will be the six-week
effect of the drug on cognitive function, which is a principal deficit in
schizophrenia patients.

Dr. Kinneret Savitsky, CEO of BioLineRx, stated,“The recent re-analysis of
BL-1020's EAGLE Phase IIb study, showing a substantially greater beneficial
effect of the drug on cognitive function in schizophrenia patients, as
compared to the original analysis of the study, has increased our confidence
in the potential of this first-in-class drug candidate. This, together with
other positive ad-hoc analyses, as well as BL-1020's excellent track record in
both clinical and pre-clinical studies, has prompted us to initiate an interim
analysis of the on-going CLARITY Phase II/III trial. Assuming the recruitment
rate continues as planned, we expect to conduct a meaningful interim analysis
of the short-term cognitive effects of BL-1020 on schizophrenic patients in
the first quarter of next year. We hope that the results will reinforce our
confidence regarding the cognitive benefits of the drug, and if so, will
enable us to expedite our commercialization efforts for the further
development of this promising therapeutic candidate. We are eagerly looking
forward to the results of the interim analysis."

Earlier this month, the Company announced that a recent re-analysis of the
results of the Phase IIb EAGLE clinical trial of BL-1020 showed that, when
taking into account effects of the circadian rhythm (i.e., 24-hour time cycle)
on cognitive function of the subjects, BL-1020 is even more potent in
improving cognitive function than initially thought. The ramifications of this
re-analysis have been taken into account in the execution of the CLARITY
trial.

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
 
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