BioLineRx Provides Clarification Regarding Interim Analysis of CLARITY Trial for BL-1020

  BioLineRx Provides Clarification Regarding Interim Analysis of CLARITY Trial
  for BL-1020

Business Wire

JERUSALEM -- February 4, 2013

BioLineRx Ltd. (NASDAQ: BLRX)(TASE: BLRX), a biopharmaceutical development
company, notes that, as previously disclosed, results from the interim
analysis of the Phase II/III CLARITY clinical trial of BL-1020, a first in
class, orally available, GABA-enhanced antipsychotic for the treatment of
schizophrenia, are expected to be reported during the week of March 18, 2013.
The CLARITY trial is a randomized, double-blind trial to examine acute (6
weeks) and long-term (24 weeks) cognitive and antipsychotic efficacy, safety
and tolerability of BL-1020 on patients with acute schizophrenia. The interim
analysis will be performed on data of approximately 235 randomized patients
from 27 sites in Romania and India.

The interim analysis will be performed by a fully independent, external Data
Monitoring Committee (DMC), which will maintain complete blinding of all study
data from the Company. As a result of the analysis, the DMC will provide the
Company with an estimate of the total number of patients required in the study
in order to achieve statistical significance on the cognitive endpoints of the
study.

The Company hereby emphasizes that as the CLARITY trial is on-going and given
the double-blind trial design, BioLineRx at present has no insight into the
results of the interim analysis. Any media reports or comments by those
outside of the Company regarding the outcome of the interim results of the
CLARITY trial are merely based on speculation.

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) is currently undergoing a Phase II trial, and BL-8040 for
treating acute myeloid leukemia (AML) and other hematological cancers has
completed Phase I. In addition, BioLineRx has eight 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, the content of which does not form a part of this press
release.

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: risks and uncertainties
associated with market conditions and the satisfaction of customary closing
conditions related to the proposed offering. 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, 1-212-896-1250
grussell@kcsa.com
or
Todd Fromer, 1-212-896-1215
tfromer@kcsa.com
or
Tsipi Haitovsky, Public Relations
+972-52-598-9892
tsipih@netvision.net.il
 
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