JERUSALEM?(BUSINESS WIRE)?
BioLineRx Ltd. (NASDAQ: BLRX)
(TASE: BLRX),
a biopharmaceutical drug development company, announced today that it
has signed an exclusive, worldwide license agreement with Biokine
Therapeutics Ltd., a Clal Biotechnology Industries (CBI.TA) portfolio
company, for the development and commercialization of BL-8040 (formerly
BKT-140), a Phase II ready drug candidate for the treatment of acute
myeloid leukemia (AML), as well as other types of hematological cancer.
BL-8040 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. On the basis of data
obtained from this study, the FDA has approved an IND application.
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 and induce 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.
Dr. Kinneret Savitsky, CEO of BioLineRx, commented, ?BioLineRx has made
a strategic decision to enter the field of oncology, where there is
clearly an urgent need for next generation anti-cancer therapies
utilizing novel biological pathways. We are therefore extremely pleased
to in-license this promising Phase II ready drug, which we will
initially develop for the treatment of acute myeloid leukemia, a true
unmet medical need with very low survival rates. AML is a recognized
orphan indication both in the U.S. and the EU; therefore, we plan to
seek orphan designation status from the regulatory authorities in order
to accelerate its development plan. In addition, based on BL-8040?s
promising pre-clinical data, as well its mechanism of action, we believe
it can be utilized for several other related oncology indications and we
intend to explore these possibilities as well. We look forward to the
upcoming Phase II clinical study for evaluating BL-8040?s efficacy on
AML patients, which is expected to commence in the first half of 2013.?
?We are very happy that BioLineRx will further develop this promising
anti-cancer agent, and are confident that BioLineRx?s experience and
expertise will advance BL-8040 through the clinical development stages
in the most efficient manner,? said Professor Amnon Peled, from the Gene
Therapy Institute, Hadassah Medical Center ? Jerusalem, founder and CEO
of Biokine Therapeutics.
?CXCR4 is one of the most important?cancer
targets discovered in recent years. It is essential for multiple aspects
of cancer progression in over 70% of all cancers, including leukemia,
breast, lung, colon, and prostate cancer. BL-8040, as a CXCR4
antagonist, therefore has the potential to target and kill various
cancer cells, and studies in animal models of the disease have shown
that this agent may stimulate hematological cancer cell death. In
addition, for many blood cancers, the bone marrow provides protection
for malignant cells from chemotherapeutic agents. Therefore, by inducing
mobilization of these cells into the peripheral blood, CXCR4 antagonists
literally ?flush out? the malignant cells from their hiding places.
?We have demonstrated in pre-clinical studies that BL-8040 is very
effective in mobilizing cells out of the bone marrow, thus sensitizing
chemo-resistant cells and improving treatment with other anti-cancer
drugs,? concluded Professor Peled.
Terms of the License Agreement
There are no upfront payments due pursuant to the agreement. BioLineRx
is obligated to pay a monthly development fee ranging from $50K to $100K
for certain development services that Biokine has committed to provide
under the agreement. If the agreed-upon clinical development plan is
completed within certain defined timelines, BioLineRx is obligated to
pay Biokine a milestone payment of $250K. The agreement does not contain
any other milestone payments. Upon any sub-licensing transaction to a
third party, BioLineRx is required to pay Biokine a royalty payment on a
sliding scale, beginning at 60% of the amounts received as consideration
in connection with the sublicensing, and decreasing to 40% of such
consideration, based on the aggregate amount of BioLineRx?s investment
in the project. Closing of the transaction is subject to formal approval
of the Office of the Chief Scientist of Israel?s Ministry of Industry,
Trade and Labor.
About Acute Myeloid Leukemia (AML)
AML is a very aggressive form of leukemia, characterized by uncontrolled
proliferation of immature white blood cells called myeloid cells in the
bone marrow and peripheral circulation. AML is the most common form of
adult acute leukemia, accounting for 80% of all diagnosed cases, with
approximately 13,000 new cases diagnosed in the U.S., as well as 30,000
new cases diagnosed in the seven leading markets, in 2011. The incidence
of AML is expected to further increase as the population of developed
countries continues to age.
AML is currently treated with a combination of chemotherapeutic agents
and stem cell transplantation. However, the past 20 years have seen
little improvement in overall patient survival rates, which are less
than 25% within five years from diagnosis. Accordingly, AML is
considered a true unmet medical need and there is a significant urgency
for developing more effective and tolerable treatments for AML patients,
particularly those with relapsed or refractory disease. The AML
therapeutics market was estimated at $200 million in 2010, and it is
projected to significantly grow with the development of new targeted
therapies, reaching over $600 million by 2017. The total leukemia
therapeutics market was valued at $6.3 billion in 2010, and is expected
to reach $11.3 billion by 2020.
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) has commenced a Phase II
trial, and BL-8040 for treating acute myeloid leukemia (AML) 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 www.biolinerx.com.
Various statements in this release concerning BioLineRx?s future
expectations, plans and prospects, 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 22, 2012. 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.
Article source: http://finance.yahoo.com/news/biolinerx-licenses-novel-phase-ii-110000227.html
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