|[March 10, 2014]
BioLineRx Completes Dose Escalation Stage of Phase 1/2 Study for Novel Celiac Treatment
JERUSALEM --(Business Wire)--
BioLineRx (NASDAQ: BLRX)(TASE: BLRX), a clinical-stage biopharmaceutical
company dedicated to identifying, in-licensing and developing promising
therapeutic candidates, announced today that the Company's novel
treatment for celiac disease, BL-7010, has successfully completed the
single administration, dose-escalation stage of the on-going Phase 1/2
clinical study. No serious adverse events were reported and there were
no dose-limiting safety issues. Based on these positive safety and
tolerability results, the Company will proceed with the repeated
administration stage of the study. Results are expected in mid-2014.
The Phase 1/2 study, taking place at Tampere Hospital in Finland, a
world-leading site for celiac disease research, is a two-part (single
and repeated administration), double-blind, placebo-controlled, dose
escalation study of BL-7010 in up to 24 well-controlled celiac patients.
The primary objective of the study is to assess the safety of single and
repeated ascending doses of BL-7010 in the study patients. Secondary
objectives include an assessment of the systemic exposure, if any, of
BL-7010 in the patients.
During the first part of the study, six dose levels of BL-7010 were
evaluated compared to placebo. The escalation stage reached the highest
planned dose, and although the study remains blinded at this point, no
serious or dose-limiting adverse events were reported and all planned
doses were found to be safe and well-tolerated. Consequently, all
patients completed their participation in this part of the study. Based
on these encouraging safety and tolerability results, the study will now
progress to the repeated administration stage, in which each patient
will receive either BL-7010 or placebo for 14 days, three times per day.
"BL-7010 for the treatment of celiac disease is one of our lead
development programs, and we are very happy to see that it is safe and
well tolerated - even at very high doses that are significantly above
the expected clinical efficacious dose," said Dr. Kinneret Savitsky,
Chief Executive Officer of BioLineRx. "BL-7010 is a unique and very
promising product, with excellent pre-clinical efficacy and safety
results. We expect to report the full results of the current Phase 1/2
study in mid-2014 and assuming they are successful, we expect to
commence a randomized, controlled efficacy study in celiac patients by
the end of this year."
"Celiac disease is highly prevalent throughout the world, with over 1%
of the global population suffering from this disease. Nevertheless,
there are currently no approved celiac therapies aside from a strict and
lifelong gluten-free diet, which is exceptinally difficult and costly
to maintain. Despite the significant need for new treatments, there are
only a handful of clinical-stage projects under development worldwide
for this disease, which we view as a significant opportunity for our
product," concluded Dr. Savitsky.
BL-7010 is a novel, non-absorbable, orally
available 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, preventing the absorption of
gliadin into the blood. The safety and efficacy of BL-7010 were
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. The celiac market is projected to reach $8
billion by 2019. 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.
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
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; BL-8040 for treating acute myeloid
leukemia (AML) and other hematological indications, which is in the
midst of a Phase 2 study; BL-7010 for celiac disease, which in the midst
of a Phase 1/2 study; and BL-5010 for non-surgical removal of skin
lesions, which is expected to commence a pivotal CE-mark registration
trial in the first half of 2014.
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 (News - Alert) 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 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
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