BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development
company, announced today that the results of the 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, are expected during the week beginning March 18, 2013.
The interim analysis 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
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.
Dr. Kinneret Savitsky, CEO of BioLineRx, stated, "We are very excited
with the excellent development pace and huge potential of our lead
product, BL-1020 for the treatment of schizophrenia. Current
schizophrenia drugs are ineffective at improving the cognitive deficit
associated with the vast majority of schizophrenia patients. In our
previous Phase IIb EAGLE study on 363 patients, BL-1020 demonstrated a
significant effect on cognitive function in schizophrenia patients as an
exploratory endpoint. The current CLARITY trial is specifically designed
and powered with cognition improvement as its primary endpoint, using
the MCCB testing battery - the most widely recognized battery for
cognition. In addition, the current trial also assesses both the
short-term and long-term effects of the drug on cognition.
"BL-1020's interim analysis is an important milestone for BioLineRx; one
which we believe will greatly enhance the commercialization prospects
and market value of this promising drug. We are already seeing
significantly enhanced interest by potential partners, as evidenced by
the numerous meetings we have this week at the JP Morgan Conference in
San Francisco. We eagerly await the results of the study, which mark an
important landmark in the development of our lead product and the
Company as a whole," concluded Dr. Savitsky.
In October, 2012, the Company announced its intention to conduct an
interim analysis of the on-going Phase II/III CLARITY trial of BL-1020.
The decision followed a re-analysis of BL-1020's Phase IIb EAGLE study,
showinga substantially greater beneficial effect of the drug on
cognitive function in schizophrenia patients when compared to the
original analysis of the study, in addition to other positive ad-hoc
analyses and BL-1020's excellent track record in both clinical and
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 commenced 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.
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.
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.
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
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