TEL AVIV, Israel, August 7, 2018 /PRNewswire/ --
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage
biopharmaceutical company focused on oncology and immunology,
announced today positive results from the lead-in period of the
GENESIS trial, a double-blind, placebo-controlled Phase 3 trial
comparing BL-8040 in combination with granulocyte
colony-stimulating factor (G-CSF), to G-CSF alone, for the
mobilization of hematopoietic stem cells (HSCs) used for autologous
transplantation in multiple myeloma patients.
The open-label, single-arm, lead-in period of the study was
designed to include up to 30 patients, with Data Monitoring
Committee (DMC) review after completion of approximately 10, 20 and
30 patients, in order to assess safety and efficacy following
treatment with BL-8040 plus G-CSF. Results of the first 11 patients
show that BL-8040 in combination with standard G-CSF treatment is
safe and tolerable. In addition, the data show that 9/11 patients
(82%) reached the primary endpoint threshold of ≥ 6x106
CD34 cells/kg with only one dose of BL-8040 and in up to 2
apheresis sessions. Furthermore, 7/11 patients (64%) reached the
threshold of ≥ 6x106 CD34 cells/kg in a single apheresis
session only. These data demonstrate the potential of BL-8040
treatment to reduce the number of administrations and apheresis
sessions, as well as hospitalization costs, related to the
preparation of multiple myeloma patients for autologous HSC
transplantation.
"Autologous HSC transplantation following high-dose chemotherapy
has significantly improved outcomes for multiple myeloma patients,"
said Dr. John F. DiPersio, Chief,
Division of Oncology at the Washington
University School of Medicine, and lead investigator of the
study. "Current practice involves mobilizing HSCs from the bone
marrow to the peripheral blood, after which the cells are collected
by apheresis. Results so far show that mobilizing HSCs with a
single BL-8040 dose combined with G-CSF is not only safe and
tolerable, but also demonstrates robust efficacy regarding the
number of collected cells, and may reduce the number of required
apheresis sessions to a single session in the majority of patients.
This is a very encouraging result that, if corroborated in the
placebo-controlled part of the trial, will be of great value to
patients as well as to the medical community. I am looking forward
to participating in the trial and to potentially improving the
quality of treatment available to multiple myeloma patients."
"We are extremely encouraged by these results. Based on the
robust data received from the first 11 patients, the DMC issued a
positive recommendation to stop the lead-in part of the study and
move immediately to the randomized placebo-controlled part of the
study," stated Philip Serlin, Chief
Executive Officer of BioLineRx. "This is the first Phase 3 trial
for our lead BL-8040 program, and as such, it is an important
milestone in BL-8040's comprehensive development plan. We look
forward to the top-line results from the randomized, double-blind,
placebo-controlled part of the study, which are expected in
2020."
About the GENESIS Study
The GENESIS study is a Phase 3, randomized, double-blind,
placebo-controlled, multicenter study, evaluating the safety,
tolerability and efficacy of BL-8040 in combination with G-CSF,
compared to placebo and G-CSF, for the mobilization of CD34 HSCs
for autologous transplantation in multiple myeloma patients. The
placebo-controlled part is designed to include 177 patients in more
than 25 centers. Treatment will include 5 days of G-CSF, with a
single dose of BL-8040 or placebo on day 4 with the option to
expand treatment to up to 8 days of G-CSF and up to 2 days of
BL-8040. Apheresis for collection of CD34 cells will be performed
on day 5. An additional 3 apheresis sessions may be conducted if
needed in order to reach the goal of ≥ 6x106 mobilized
CD34 cells/kg.
The primary objective of the study is to demonstrate the
superiority of a single dose of BL-8040 in combination with G-CSF,
over placebo and G-CSF, in the mobilization of ≥ 6x106
CD34 cells/kg in up to 2 apheresis sessions, in preparation for
autologous stem cell transplantation in multiple myeloma patients.
Secondary objectives include time to engraftment of neutrophils and
platelets, durability of the engraftment, as well as safety and
other efficacy parameters.
About BL-8040
BL-8040 is a short synthetic peptide for stem cell mobilization
and for treatment of hematological malignancies and solid tumors.
It functions as a high-affinity best-in-class antagonist for CXCR4,
a chemokine receptor that is directly involved in the retention of
stems cells in the bone marrow, as well as 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.
HSCs express CXCR4 and are retained in the protective bone
marrow niche via binding to CXCL12 (also known as SDF-1).
Blocking of the CXCR4-SDF1 interaction by BL-8040 leads to the
mobilization of HSCs into the peripheral blood. In a number of
clinical and pre-clinical studies, BL-8040 has shown robust
mobilization of HSCs.
Furthermore, BL-8040 induce mobilization of leukemic cells and
immune-cells from the bone marrow, thereby sensitizing leukemic
cells to chemo- and bio-based anti-cancer therapy, as well as a
direct anti-cancer effect by inducing cell death (apoptosis).
BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was
previously developed under the name BKT-140.
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
multi-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 has initiated a Phase 3 study in stem cell
mobilization for autologous transplantation; and AGI-134, an
immunotherapy treatment in development for multiple solid tumors,
which has recently initiated a Phase 1/2a study. 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 is conducting 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
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 6, 2018. 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.
Contact:
PCG Advisory
Vivian Cervantes
Investor Relations
+1-646-863-6274
vivian@pcgadvisory.com
or
Tsipi Haitovsky
Public Relations
+972-52-598-9892
tsipihai5@gmail.com
SOURCE BioLineRx Ltd.