BioLineRx Announces Results from Interim Analysis of Phase II/III CLARITY Trial of BL-1020 for Schizophrenia

  BioLineRx Announces Results from Interim Analysis of Phase II/III CLARITY
  Trial of BL-1020 for Schizophrenia

   Management call scheduled for Wednesday, March 20^th, at 11:00 a.m. EDT

Business Wire

JERUSALEM -- March 20, 2013

BioLineRx (NASDAQ: BLRX)(TASE: BLRX), a biopharmaceutical development
company, today announced that results from a pre-planned 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, indicate that
the trial would not meet the pre-specified primary efficacy endpoint. After
conferring with the study’s independent Data Monitoring Committee (DMC), the
Company has decided to discontinue the CLARITY study. No additional patients
will be enrolled in the trial.

“These disappointing results underscore the difficulty of treating cognition
in schizophrenia, which remains an unmet medical need,” stated Kinneret
Savitsky, PhD, Chief Executive Officer of BioLineRx. “We would like to thank
the patients and investigators for their participation and engagement in the
study. While we certainly would have preferred to see a positive outcome on
this trial, the decision to perform the interim analysis, without waiting
until the end of the study, provides us with the opportunity to allocate
additional resources to our other projects in order to accelerate their
development. This confirms the advantage of our business model, which is based
on a broad pipeline with a number of compounds, at different stages of
development, and for multiple indications.”

As a result of the CLARITY study termination, the Company anticipates that
planned research and development expenses will decrease for the remainder of
2013 and part of 2014 by approximately $6 to $7 million, thus allowing the
Company’s current cash reserves of approximately $28 million to fund its
expected operations into 2015. The Company expects to meet a number of
significant clinical milestones related to other pipeline assets in the next
12-18 months.

About Phase II/III CLARITY Study Interim Analysis

The interim analysis included data on 230 subjects, of which 168 were
evaluable for analysis on the primary (six-week) cognitive endpoint. The
analysis indicated no efficacy of BL-1020, in comparison to Risperidone,
relative to the cognitive primary and secondary (12-week and 24-week)
endpoints. However, in several statistical parameters specified in the
statistical analysis plan (SAP), positive trends in cognition were observed.
The Company intends to perform a complete analysis of the un-blinded study
data on all patients enrolled to date in order to ascertain whether there may
be future potential for the product.

Conference Call and Presentation

BioLineRx's management will hold a conference call to discuss the Phase II/III
CLARITY interim analysis results for BL-1020 today, March 20, 2013, at 11:00
a.m. EDT. To access the conference call, please dial 1-866-229-7198 from the
U.S. or +972-3-918-0691 internationally. The call will also be available via
live audio webcast through BioLineRx’s website. The corresponding slides will
be available via download on the home page of BioLineRx’s website,
www.biolinerx.com, starting approximately 15 minutes before the conference
call.

A replay of the conference call will be available approximately two hours
after completion of the live conference call. To access the replay, please
dial 1-877-456-0009 from the U.S. or +972-3-925-5944 internationally. The
replay will be available through March 23, 2013.

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-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-7040 for treating
inflammatory bowel disease (IBD) is currently undergoing a Phase II trial;
BL-8040 for treating acute myeloid leukemia (AML) and other hematological
cancers will shortly commence a Phase II study; BL-1021 for neuropathic pain
is in Phase I development and BL-1020 for schizophrenia. In addition,
BioLineRx has six 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
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
12, 2013. 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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