BioLineRx Ltd. (NASDAQ: BLRX)(TASE: BLRX), a clinical-stage
biopharmaceutical company dedicated to identifying, in-licensing and
developing promising therapeutic candidates, announced today it has
in-licensed BL-1110, a novel compound for the treatment of neuropathic
pain. BL-1110 may also be developed for the treatment of scleroderma, an
autoimmune disease characterized by a hardening and tightening of the
skin and connective tissues. The compound, which had been previously
developed as part of BioLineRx's Early Development Program under the
name EDP-34, was in-licensed from the University of Colorado.
Neuropathic pain is caused by damage or diseases affecting the nervous
system, and usually does not respond well to regular painkillers. One of
the most potent drugs for the treatment of neuropathic pain is morphine;
however, its efficacy is often significantly limited due to the body's
development of tolerance to the drug, as well as its severe side
effects. Morphine can create neuroinflammation in the central nervous
system, which has been linked to the suppression of morphine analgesia,
as well as the enhancement of morphine-induced tolerance, dependence and
reward associated with drug abuse. Recent studies show part of these
neuroinflammatory effects are triggered by the interaction of morphine
with glial cells, which are highly prevalent in the central nervous
system. BL-1110, which was invented by Prof. Linda R. Watkins from the
Psychology and Neuroscience Department, and Prof. Hang Hubert Yin from
the Chemistry and Biochemistry Department - both from the University of
Colorado at Boulder, blocks the interaction of morphine with glial
cells, thereby enhancing the analgesic effect of morphine, and reducing
concurrent adverse effects and inflammatory processes.
BL-1110 is a small molecule that targets the critical TLR4/MD-2 complex
formation, thus preventing the binding of morphine to the TLR4 receptor
in glial cells. BL-1110 is administered orally, together with morphine
or other opioids. In preclinical studies in rats, BL-1110 was shown to
enhance the effects of morphine. Furthermore, the studies show the drug
penetrates the blood-brain barrier and reaches the central nervous
system with high efficiency, that it is safe for use and that it does
not induce adverse effects at doses that are much higher than the
"BL-1110 works through a novel mechanism-of-action, based on our recent
discovery that opioids, such as morphine, cause the activation of glial
cells. This glial activation results in the release of pro-inflammatory
factors, which suppress the desired opioid-induced neuronal analgesic
effect, thereby reducing the efficacy of the opioid. Furthermore,
evidence suggests that glial activation contributes to the development
of opioid tolerance, dependence and abuse," explained Prof. Hang Hubert
Yin. We therefore have high hopes that BL-1110 will be a valuable
companion to opioid therapies, enhancing their efficacy and reducing
their negative side effects."
"Neuropathic pain is a major health problem affecting the quality of
life of millions of people around the globe on a daily basis. Despite
its widespread occurrence, it is notoriously difficult to treat.
Opioids, such as morphine, are a potent option for the treatment of
neuropathic pain, but they are generally not used as a first-line
treatment due to the considerable risk of adverse side effects,
tolerance and dependence.
BL-1110 offers the possibility of mitigating morphine tolerance and side
effects while enhancing the analgesic effect. This drug could offer a
real breakthrough for the treatment of this challenging and persistent
pathology. We are therefore very pleased to in-license this drug and
continue its development," said Dr. Kinneret Savitsky, CEO of BioLineRx.
About Neuropathic PainNeuropathic pain develops as a result
of damage to, or dysfunction of, the nervous system and is often a
chronic condition. The causes of neuropathic pain can include shingles,
diabetes and cancer, but in many cases the underlying pathology is not
completely understood. Neuropathic pain does not usually respond to
regular pain killers, and can be very difficult to treat; only
approximately 50% of patients achieve even partial relief. Annual sales
of prescription drugs for neuropathic pain exceed $6 billion in the
seven major markets.
About BL-1110BL-1110, developed by BioLineRx under its
Early Development Program and previously known as EDP 34, is an
orally-administered small molecule designed to block the binding of
morphine to the toll-like receptor-4 (TLR4) on glial cells. Research
shows that besides the activity of opioids on opioid receptors in the
neurons, opioids cause activation of glial cells via the TLR4 signaling
pathway, which activation results in the release of cytokines and other
pro-inflammatory factors that suppress the desired opioid-induced
neuronal analgesic effect, thereby reducing the efficacy of the opioid.
Furthermore, evidence suggests that glial activation by opioids
contributes to the negative side effects of opioid therapy, such as
tolerance, dependence and reward associated with drug abuse. BL-1110
prevents morphine- binding to TLR4 receptors on glial cells, resulting
in an enhanced analgesic effect and reduced side effects. BL-1110 was
invented by Prof. Linda R. Watkins and Prof. Hang Hubert Yin and was
in-licensed by BioLineRx from the University of Colorado.
About BioLineRxBioLineRx 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; and BL-7010 for celiac disease, which is in
the midst of a Phase 1/2 study.
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-1110, 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 17, 2014. 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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