BioLineRx Receives Regulatory Approval to Commence Phase II Clinical Trial for BL-8040, for Treatment of Leukemia

  BioLineRx Receives Regulatory Approval to Commence Phase II Clinical Trial
  for BL-8040, for Treatment of Leukemia

                     Partial results expected in Q4 2013

                      Final results expected in H2 2014

Business Wire

JERUSALEM -- April 10, 2013

BioLineRx (NASDAQ:BLRX)(TASE:BLRX), a biopharmaceutical development company,
announced today that it has received all necessary regulatory approvals in the
US to commence a Phase IIa trial for BL-8040, for the treatment of Acute
Myeloid Leukemia (AML).

The study is a multicenter, open-label study under an IND, designed to
evaluate the safety and efficacy profile of repeated escalating doses of
BL-8040 in adult subjects with relapsed/refractory AML. The primary endpoints
of the study are the safety and tolerability of the drug. Secondary endpoints
will include the pharmacokinetic profile of the drug and an efficacy
evaluation, as assessed by various parameters, such as the response rate by
bone marrow biopsy. The study is also designed in a way that will enable the
investigators to evaluate the capabilities of BL-8040 in mobilizing cancer
cells from the bone marrow to the peripheral blood, and in inducing their cell
death. The study is expected to be conducted in the U.S. and Israel, and will
enroll up to 50 patients.

“This program is generating a lot of enthusiasm from our clinical research
partners, and we are very pleased that several renowned and respected
investigators will be leading our study in the U.S. and Israel,” said Kinneret
Savitsky, PhD, CEO of BioLineRx. “AML is one of the most common types of
leukemia in adults, yet survival rates continue to be low relative to other
leukemias. In particular, treatment options for patients with relapsed or
refractory AML are extremely limited, and in many cases, only palliative care
is offered. We look forward to the partial results expected towards the end of
this year, and have sincere hopes that BL-8040 will be a significant and
efficient addition in the battle with this devastating disease.”

“We are honored to collaborate with BioLineRx on this exciting project,” said
Dr. Gautam Borthakur, the principal investigator of the trial at the MD
Anderson Cancer Center in Houston, Texas. “BL-8040 has a unique mechanism of
action and has shown very promising pre-clinical and clinical results.
Specifically, in pre-clinical studies, BL-8040 showed a CXCR4-dependent,
preferential anti-tumor effect against human-derived AML cells. Therefore, we
are very pleased to be able to offer this novel therapeutic opportunity to our
patients, particularly since AML is still such a big unmet medical need.”

About BL-8040
BL-8040 is a clinical-stage drug candidate for the treatment of acute myeloid
leukemia, as well as other types of hematological cancers. It is a short
peptide that functions as a high-affinity antagonist for CXCR4, a chemokine
receptor that is directly involved in tumor progression, angiogenesis (growth
of new blood vessels in the tumor), metastasis (spread of the disease to other
organs or organ parts) and cell survival. CXCR4 is over-expressed in more than
70% of human cancers and its expression often correlates with disease
severity. In a Phase I/II, open-label, dose escalation, safety and efficacy
clinical trial in 18 multiple myeloma patients, BL-8040 demonstrated an
excellent safety profile at all doses tested and was highly effective in the
mobilization of hematopoietic stem cells and white blood cells from the bone
marrow to the peripheral blood.

BL-8040 also mobilizes cancer cells from the bone marrow and other sites and
may therefore sensitize these cells to chemo- and bio-based anti-cancer
therapy. It has also demonstrated a direct anti-cancer effect by inducing
apoptosis (cell death). Pre-clinical studies show that BL-8040 is efficient,
both alone and in combination with the anti-cancer drug Rituximab, in reducing
bone marrow metastasis of lymphoma cells and stimulating lymphoma cell death.
BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously
developed under the name BKT-140.

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, the content of which does not form a part of this press

Various statements in this release concerning BioLineRx’s future expectations,
including specifically those related to the development and commercialization
of BL-8040, 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.


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