BioLineRx Announces Pre-clinical Results Demonstrating the Safety of BL-7010, an Oral Treatment for Celiac Disease and Gluten

  BioLineRx Announces Pre-clinical Results Demonstrating the Safety of
  BL-7010, an Oral Treatment for Celiac Disease and Gluten Sensitivity

- The new safety data, as well as pre-clinical efficacy results, presented at
                the Better Life for Coeliacs 2012 Conference –

Business Wire

JERUSALEM -- September 10, 2012

BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development
company, announced today that BL-7010, an orally available treatment for
celiac disease, was found to be safe and well tolerated in pre-clinical
studies conducted to date. The new findings were delivered in an oral
presentation by Professor Elena Verdú, Division of Gastroenterology,
Department of Medicine, McMaster University, Hamilton, Ontario, at the Better
Life for Coeliacs 2012 Conference, held in Helsinki, Finland from September
6^th-9^th. In her talk, Prof. Verdú also presented previously disclosed
pre-clinical data demonstrating that BL-7010 reduces gluten toxicity, which
were published in the in leading medical journal Gastroenterology.

In pre-clinical studies BL-7010 was found to be safe, well tolerated and did
not cause any clinical adverse effects, even in very high doses. Additional
studies showed that BL-7010 is specific to gliadins, the immunogenic peptides
present in gluten that cause celiac disease, and does not interact with
non-related enzymes or vitamins in the digestive tract. These results imply
that BL-7010 will not affect the absorbance of vitamins or the digestion
process and therefore will not lead to malnutrition.

"These new findings for BL-7010, in addition to the pre-clinical efficacy data
are very encouraging, especially since BL-7010 was found to be safe and
without adverse effects in laboratory animals even in doses much higher than
the expected clinically effective dose. Currently, the only effective
treatment for celiac is a gluten free diet, which is extremely difficult to
maintain, and significantly affects the quality of life of people with celiac
disease. Therefore, there is a critical need for developing a safe and
effective drug that could help, alongside the dietary restrictions, in
preventing damage caused to the digestive tract by gluten," said Professor
Elena Verdú, who presented the data. "BL-7010 may attenuate the immune
response to gluten and reduce subsequent damage to the small intestine, and
may therefore be an effective adjuvant therapy that will improve the quality
of life for people with celiac disease throughout the world.”

Additional efficacy studies indicate that BL-7010 reduces digestion of wheat
gluten, thereby decreasing its toxicity. In addition, BL-7010 attenuates the
immune response to gluten in rodents and prevents gluten-induced pathological
damage to the small intestine. BL-7010 is not absorbed systemically,
indicating its safety as a gluten-neutralizing substance. These data
demonstrate that BL-7010 has the potential to be an effective adjunctive
therapy to the gluten-free diet, to prevent or reduce gluten-induced disorders
in humans.

About BL-7010

BL-7010 is a novel, non-absorbable, orally available polymer intended for the
treatment of celiac disease and gluten sensitivity. It has a high affinity for
gliadins, the immunogenic peptides present in gluten that cause celiac
disease. By binding to gliadins, BL-7010 effectively masks them from the
immune system in the digestive tract, and the BL-7010-gliadin complex is
eventually excreted from the digestive tract. This significantly reduces the
immune response triggered by gluten.

About Celiac Disease and Gluten Sensitivity

Celiac disease (CD) is a chronic, autoimmune, inflammatory disease of the
small intestine characterized by damage to the lining of the small intestine
and typically leads to dyspepsia, malabsorption and a variety of other
symptoms. It occurs in genetically predisposed individuals and is caused by an
immunological reaction to gluten, found in wheat, barley and rye. Estimates
suggest that 1% of the world’s population is affected by celiac disease, and
prevalence is expected to increase dramatically with improved diagnosis and
awareness of the disease. Today there are no pharmacological agents approved
for CD and the only treatment option is a life-long, strict, gluten-free diet,
which is difficult to maintain both due to food contamination with gluten, as
well as eating habits in a social setting. Non-celiac gluten sensitivity is a
common name for cases of gluten reactions in which neither allergic nor
autoimmune mechanisms are involved or can be identified.

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

Various statements in this release concerning BioLineRx’s future expectations,
including specifically those related to the development and commercialization
of BL-7010, 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.


KCSA Strategic Communications
Garth Russell / Todd Fromer
1 212-896-1250 / 1 212-896-1215 /
Tsipi Haitovsky
Public Relations
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