Study will be conducted in collaboration
with Washington University School of Medicine, Division of
Hematology and Oncology
BioLineRx Ltd. (NASDAQ/TASE:BLRX), a clinical-stage
biopharmaceutical company dedicated to identifying, in-licensing
and developing promising therapeutic candidates, announced today
the filing of regulatory submissions required to commence a Phase 2
trial for BL-8040 as a novel approach for mobilization and
collection of bone marrow stem cells from the peripheral blood
circulation. The trial is expected to commence shortly after
receipt of regulatory approval, anticipated in the first quarter of
2016.
The Phase 2 open-label study will be conducted as an
investigator-initiated study in collaboration with Washington
University School of Medicine, Division of Oncology and Hematology,
and will enroll up to 24 donor/recipient pairs. The study
submission was made following a meeting with the FDA in October
2015 to discuss the BL-8040 stem cell mobilization development
program. The trial will evaluate the ability of BL-8040 to promote
stem cell mobilization as a single agent in the allogeneic
transplantation setting. Donors between 18 and 70 years of age and
their HLA-matching recipients, diagnosed with advanced
hematological malignancies that require stem cell transplantation,
will be recruited to the study. On the donor side, the primary
endpoint of the study is the ability of a single injection of
BL-8040 to mobilize sufficient amounts of cells for transplantation
following up to two leukapheresis collections. On the recipient
side the study aims to evaluate the functionality and engraftment
following transplantation of the BL-8040 collected graft.
The safety and tolerability of BL-8040 in the healthy donors
will be evaluated. In addition, graft durability, the incidence of
grade 2-4 acute graft versus host disease (GvHD), and other
recipient related parameters will be evaluated in the patients who
have undergone transplantation of hematopoietic cells mobilized
with BL-8040.
Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx,
stated, “Stem cell mobilization is used increasingly as a method of
collecting hematopoietic stem cells for transplantation, forming
part of the treatment regimen for certain types of hematological
cancers, as well as for severe anemia or immune deficiency
disorders. We have already completed a successful Phase 1 safety
and efficacy study in healthy volunteers, supporting BL-8040 as
one-day, single-dose collection regimen, with the capacity to
rapidly mobilize substantial amounts of stem cells, representing a
significant improvement upon the current standard of
care. Following a productive meeting with the FDA regarding
the development program for BL-8040 as a stem cell mobilizer for
allogeneic transplantation, and in light of the fact that there are
no approved drugs for stem cell mobilization to support allogeneic
transplant, we are looking forward to shortly commencing yet
another Phase 2 trial for our lead oncology platform.”
“In parallel, BL-8040 is also undergoing a Phase 2 study for
treating relapsed and refractory acute myeloid leukemia patients,
and has recently initiated a Phase 2b study as an AML consolidation
treatment and a Phase 1/2 study as a novel treatment for hMDS
and AA, two bone marrow failure conditions. In addition, as we
recently announced, we are also performing an extensive evaluation
of BL-8040’s potential in the immuno-oncology space, as a
combination treatment with immune checkpoint inhibitors,” added Dr.
Savitsky.
About BL-8040BL-8040 is a clinical-stage drug candidate
for the treatment of acute myeloid leukemia, as well as other
hematological indications. 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. BL-8040 is currently in the
midst of a Phase 2 study for relapsed/refractory acute myeloid
leukemia (AML) and has recently initiated a Phase 2b study as an
AML consolidation treatment and a Phase 1/2 study in hMDS and AA,.
In addition, in a Phase 1/2, open-label, dose escalation, safety
and efficacy clinical trial in 18 multiple myeloma patients,
BL-8040, when combined with G-CSF, demonstrated an excellent safety
profile at all doses tested and was highly effective in the
mobilization of hematopoietic stem cells and white blood cells from
the bone marrow to the peripheral blood. Additionally, in a Phase 1
stem-cell mobilization study in healthy volunteers, BL-8040 as a
single agent was safe and well tolerated at all doses tested and
resulted in efficient stem-cell mobilization and collection in all
study participants. Importantly, the results of this study support
the use of BL-8040 as one-day, single-dose collection regimen,
which is a significant improvement upon the current standard of
care.
BL-8040 effectively mobilizes cancer cells from the bone marrow
and may therefore sensitize these cells to chemo- and bio-based
anti-cancer therapy. Importantly, BL-8040 has also demonstrated a
direct anti-cancer effect by inducing apoptosis. Pre-clinical
studies show that BL-8040 inhibits the growth of various tumor
types including multiple myeloma, non-Hodgkin’s lymphoma, leukemia,
non-small cell lung carcinoma, neuroblastoma and melanoma. BL-8040
also significantly and preferentially stimulated apoptotic cell
death of malignant cells (multiple myeloma, non-Hodgkin’s lymphoma
and leukemia). Significant synergistic and/or additive tumor cell
killing activity has been observed in vitro and in vivo when tumor
cells were treated with BL-8040 together with Rituximab,
Bortezomib, Imatinib, Cytarabine and the FLT-3 inhibitor AC-220
(in NHL, MM, CML, AML, and AML-FLT3-ITD models, respectively).
BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was
previously developed under the name BKT-140.
About Stem Cell MobilizationHigh-dose chemotherapy
followed by stem cell transplantation has become an established
treatment modality for a variety of hematologic malignancies,
including multiple myeloma, as well as various forms of lymphoma
and leukemia. Modern peripheral stem-cell harvesting often replaces
the use of traditional surgical bone marrow stem-cell harvesting.
In the modern method, stem cells are mobilized from the bone marrow
using granulocyte colony-stimulating factor (G-CSF), often with the
addition of a mobilizing agent such as Plerixafor (Mozobil),
harvested from the donor’s peripheral blood by apheresis, and
infused to the patient after chemotherapy ablation treatment. This
treatment is highly effective, the peripheral stem cells are easier
to collect, and the treatment allows for a quicker recovery time
and fewer complications.
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
commercialization.
BioLineRx’s current portfolio consists of a variety of clinical
and pre-clinical projects, including: BL-8040, a cancer therapy
platform, which is in the midst of a Phase 2 study for
relapsed/refractory AML, has recently initiated a Phase 2b study as
an AML consolidation treatment, has recently initiated a Phase 1/2
study in hMDS and AA, 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-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 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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version on businesswire.com: http://www.businesswire.com/news/home/20151214005564/en/
PCG AdvisoryVivian CervantesInvestor
Relations212-554-5482vivian@pcgadvisory.comorTsipi HaitovskyPublic
Relations+972-3-624-0871tsipihai5@gmail.com
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