TEL AVIV, Israel, Aug 21,
2017 /PRNewswire/ --BioLineRx Ltd. (NASDAQ: BLRX)
(TASE:BLRX), a clinical-stage biopharmaceutical company focused on
oncology and immunology, announced today the filing of regulatory
submissions required to commence a randomized, controlled Phase 3
registrational trial of BL-8040 for the mobilization of
hematopoietic stem cells for autologous transplantation in patients
with multiple myeloma. The trial, named GENESIS, is expected to
commence by the end of 2017, following receipt of regulatory
approvals.
The Phase 3 GENESIS trial is aimed at evaluating the safety,
tolerability and efficacy of the combination treatment of BL-8040
and granulocyte colony-stimulating factor (G-CSF), as compared
to the control arm of placebo and G-CSF. The trial will be
conducted in two parts: The first part, designed to validate the
optimal dosing of BL-8040, is a lead-in, open-label, multi-center
study that will include 10-30 patients, in order to assess the
efficacy and safety of treatment with BL-8040 and G-CSF. This part
will be followed by a randomized, placebo-controlled, multi-center
study in approximately 180 patients. The primary endpoint will be
the proportion of subjects mobilizing ≥6.0 x
106 CD34+ cells/kg with up to 2 apheresis sessions
in preparation for autologous transplantation after a single
administration of BL-8040 and G-CSF, as compared to placebo and
G-CSF.
Philip Serlin, Chief Executive
Officer of BioLineRx, stated, "We are excited to move forward with
BL-8040 into a Phase 3 registration study. We have previously
reported positive results supporting BL-8040 as a one-day dosing
and up-to-two-day collection regimen for rapid mobilization of stem
cells. This represents a significant improvement over the current
treatment, which requires four-to-eight daily injections of G-CSF
and one-to-four apheresis sessions. We therefore hope that this
Phase 3 trial will further support these results and help improve
the standard of care for multiple myeloma patients."
"In parallel, we are continuing to expand the potential of our
robust BL-8040 oncology platform, by advancing multiple clinical
studies for additional indications that are ongoing or expected to
commence during 2017. These include a large, randomized, controlled
Phase 2b study in AML, as well as several Phase 2 combination
studies with immune checkpoint inhibitors in solid tumors and
hematological malignancies," added Mr. Serlin.
About BL-8040
BL-8040 is a short peptide for the treatment of acute myeloid
leukemia, solid tumors, and stem cell mobilization. It functions as
a high-affinity antagonist for CXCR4, a chemokine receptor that is
directly involved in tumor progression, angiogenesis, metastasis
and cell survival. CXCR4 is over-expressed in more than 70% of
human cancers and its expression often correlates with disease
severity. In a number of clinical and pre-clinical studies, BL-8040
has shown robust mobilization of cancer cells from the bone marrow,
thereby sensitizing these cells to chemo- and bio-based anti-cancer
therapy, as well as a direct anti-cancer effect by inducing cell
death (apoptosis). In addition, BL-8040 has also demonstrated
robust stem-cell mobilization, including the mobilization of
colony-forming cells, T, B and NK cells. BL-8040 was licensed by
BioLineRx from Biokine Therapeutics and was previously developed
under the name BKT-140.
About Stem Cell Mobilization
High-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. Stem cells are mobilized
from the bone marrow using granulocyte colony-stimulating factor
(G-CSF), harvested from the peripheral blood by apheresis, and
infused to the patient after chemotherapy. This type of treatment
often replaces the use of traditional bone marrow transplantation,
because the stem cells are easier to collect and the treatment
allows for a quicker recovery time and fewer complications.
About BioLineRx
BioLineRx is a clinical-stage biopharmaceutical company focused
on oncology and immunology. The Company in-licenses novel
compounds, develops them through pre-clinical and/or clinical
stages, and then partners with pharmaceutical companies for
advanced clinical development and/or commercialization.
BioLineRx's leading therapeutic candidates are: BL-8040, a
cancer therapy platform, which has successfully completed a Phase
2a study for relapsed/refractory AML, is in the midst of a Phase 2b
study as an AML consolidation treatment and is expected to initiate
a Phase 3 study in stem cell mobilization for autologous
transplantation; and AGI-134, an immunotherapy treatment in
development for multiple solid tumors, which is expected to
initiate a first-in-man study in the first half of 2018. In
addition, BioLineRx has a strategic collaboration with Novartis for
the co-development of selected Israeli-sourced novel drug
candidates; a collaboration agreement with MSD (known as Merck in
the US and Canada), on the basis
of which the Company has initiated a Phase 2a study in pancreatic
cancer using the combination of BL-8040 and Merck's
KEYTRUDA®; and a collaboration agreement with Genentech,
a member of the Roche Group, to investigate the combination of
BL-8040 and Genentech's Tecentriq® (Atezolizumab) in
several Phase 1b/2 studies for multiple solid tumor indications and
AML.
For additional information on BioLineRx, please visit the
Company's website at www.biolinerx.com, where you can review
the Company's SEC filings, press releases, announcements and
events. BioLineRx industry updates are also regularly updated
on Facebook, Twitter, and LinkedIn.
Various statements in this release concerning BioLineRx's
future expectations 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,
2017. 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.
Contacts:
PCG Advisory
Vivian Cervantes
Investor Relations
+1-212-554-5482
vivian@pcgadvisory.com
or
Tsipi Haitovsky
Public Relations
+972-52-989892
tsipihai5@gmail.com
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SOURCE BioLineRx Ltd.