BioLineRx Announces BL-8040, for the Treatment of Leukemia and Other Types of Hematological Cancer, to be Presented at 2012 ASH

  BioLineRx Announces BL-8040, for the Treatment of Leukemia and Other Types
  of Hematological Cancer, to be Presented at 2012 ASH Annual Meeting

ASH 2012

Business Wire

JERUSALEM -- November 07, 2012

BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development
company, announced today that in vivo and in vitro data demonstrating the
efficacy of BL-8040 in treating chronic myeloid leukemia (CML) has been
accepted for presentation at the 2012 American Society of Hematology (ASH)
annual meeting, the premier hematology scientific conference, to take place in
Atlanta, Georgia on December 8-11, 2012.

BL-8040 (formerly BKT-140) is a clinical-stage drug candidate for the
treatment of acute myeloid leukemia (AML), as well as other types of
hematological cancer. 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 16 multiple
myeloma patients, BL-8040 demonstrated an excellent safety profile and was
well tolerated at all doses tested.

BioLineRx intends to commence the next clinical studies for evaluating
BL-8040’s efficacy on AML and acute lymphoblastic leukemia (ALL) patients in
the first half of 2013 and will conduct preparatory sessions at the ASH
meeting with the principal investigators from the main U.S. sites.

BL-8040 has been shown to induce the mobilization of healthy hematopoietic
stem cells from the bone marrow into the peripheral blood. BL-8040 also
mobilizes cancer cells from the bone marrow and other sites and may therefore
expose 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.

In September, BioLineRx announced the signing of an exclusive, worldwide
license agreement with Biokine Therapeutics Ltd., a Clal Biotechnology
Industries (TASE: CBI) portfolio company, for BioLineRx to develop and
commercialize BL-8040.

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 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


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