BioLineRx Ltd. (NASDAQ: BLRX; TASE: BLRX), a clinical-stage
biopharmaceutical company dedicated to identifying, in-licensing and
developing promising therapeutic candidates, announced today that it
will present positive safety results of its Phase 1/2 study for BL-7010,
a novel polymer for the treatment of celiac disease, at the 16th
International Celiac Disease Symposium (ICDS 2015), to take place from
June 21-24 in Prague, Czech Republic. The Phase 1/2 results were
previously announced in November 2014.
Yotam Nisemblat, BioLineRx Drug Development Director, will present the
data in a talk titled BL-7010,
a Novel Potential Treatment of Celiac Disease - a Phase 1/2 Safety Study
in Celiac Patients, on Wednesday, June 24, in the Novel
Treatments session. BL-7010 was found to be safe and well tolerated
in the single-dose phase, and the optimal safe dose for future
development was determined in the repeated-dose phase. The Company is in
the final stages of additional non-clinical studies and formulation
development for BL-7010 in preparation for the upcoming randomized,
placebo-controlled efficacy study, which is expected to commence in the
fourth quarter of 2015.
About BL-7010
BL-7010 is a novel, non-absorbable, orally available co-polymer intended
for the treatment of celiac disease. It has a high affinity for
gliadins, the immunogenic proteins present in gluten that cause celiac
disease. By sequestering gliadins, BL-7010 effectively masks them from
enzymatic degradation and prevents the formation of immunogenic peptides
that trigger the immune system. This significantly reduces the immune
response triggered by gluten. BL-7010 is excreted with gliadin from the
digestive tract and is not absorbed into the blood. The safety and
efficacy of BL-7010 have been demonstrated in pre-clinical studies.
BL-7010 was invented by Prof. Jean-Christophe Leroux from the Department
of Chemistry and Applied Biosciences, Institute of Pharmaceutical
Sciences, ETH Zurich, Switzerland, and is being developed by BioLineRx
under a worldwide exclusive license agreement with Univalor.
About Celiac Disease
Celiac disease 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. There are
currently no treatments approved for celiac disease 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.
About BioLineRx
BioLineRx is a publicly-traded, clinical-stage biopharmaceutical company
dedicated to identifying, in-licensing and developing promising
therapeutic candidates. The Company in-licenses novel compounds
primarily from academic institutions and biotech companies based in
Israel, develops them through pre-clinical and/or clinical stages, and
then partners with pharmaceutical companies for advanced clinical
development and/or commercialization.
BioLineRx’s current portfolio consists of a variety of clinical and
pre-clinical projects, including: BL-1040 for prevention of pathological
cardiac remodeling following a myocardial infarction, which has been
out-licensed to Bellerophon BCM (f/k/a Ikaria) and is in the midst of a
pivotal CE-Mark registration trial scheduled for completion in mid-2015;
BL-8040, a cancer therapy platform, which is in the midst of a Phase 2
study for acute myeloid leukemia (AML), and has successfully completed a
Phase 1 study in stem cell mobilization; and BL-7010 for celiac disease,
which has successfully completed a Phase 1/2 study.
In December 2014, BioLineRx entered into a strategic collaboration
with Novartis for the co-development of selected Israeli-sourced novel
drug candidates. The companies intend to co-develop a number of
pre-clinical and early clinical therapeutic projects through clinical
proof-of-concept for potential future licensing by Novartis.
For more information on BioLineRx, please visit www.biolinerx.com
or download the investor relations mobile device app, which allows users
access to the Company’s SEC documents, press releases, and events.
BioLineRx’s IR app is available on the iTunes App Store as well as the
Google Play Store.
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 23, 2015. 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.
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