TEL AVIV, Israel, June 18, 2018 /PRNewswire/ -- BioLineRx Ltd.
(NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical
company focused on oncology and immunology, announced today that
new data presented at the 23rd Annual Congress of the European
Hematology Association (EHA), held in Stockholm, Sweden, shows that BL-8040,
combined with high dose cytarabine (HiDAC), significantly enhanced
overall survival in difficult-to-treat relapsed or refractory AML
(r/r AML) patients in a Phase 2a clinical trial. In addition, an
important new finding shows a statistically significant correlation
between patient response and the mobilization of AML blasts.
Responding patients demonstrated a clear and significant increase
in the number of AML blasts in the peripheral blood following
BL-8040 treatment, whereas non-responding patients were largely
unaffected.
"We are extremely pleased to see further significant improvement
in overall survival for this very difficult-to-treat patient
population, as data continues to accumulate from our Phase 2a
proof-of-concept study in relapsed or refractory AML," stated
Philip A. Serlin, Chief Executive
Officer of BioLineRx. "In addition, exciting new findings indicate
a clear correlation between patient response and mobilization of
AML blasts, thus identifying a potential biomarker for selecting
patients likely to respond to BL-8040. These encouraging results
strongly support the continued development of BL-8040 in relapsed
or refractory AML, giving BioLineRx broad therapeutic coverage in
the AML space, with potential activity at different stages of the
disease and in different patient populations. We look forward to
providing additional updates on overall survival from this study,
and continue to execute on our other two important AML trials
currently ongoing – a large, randomized, controlled Phase
2b study in consolidation AML, and a
Phase 1b/2 study in maintenance of
AML under our collaboration with Genentech," added Mr. Serlin.
The Phase 2a study consisted of 42 patients in two cohorts: (i)
dose-escalation (range 0.5-2.0 mg/kg) and (ii) dose-expansion at
the selected dose of 1.5 mg/kg. Patients with r/r AML were treated
daily with BL-8040 monotherapy for two days followed by combined
administration of BL-8040 and HiDAC for 5 days, for 1-2 cycles.
Efficacy endpoints included response rate (CR/CRi), overall
survival, duration of response and event-free survival.
BL-8040 in combination with HiDAC was safe and well tolerated at
all BL-8040 dose levels (range 0.5-2.0 mg/kg). The response rate
for all dosing levels was 29% and median overall survival was 9.1
months, compared with historical data on overall survival of 6.1
months for HiDAC alone. In patients receiving the 1.5 mg/kg dose
selected for expansion (n=23), the response rate was 39% and median
overall survival was 10.7 months with 1-year, 2-year and 3-year
survival rates of 38.1%, 23.8% and 23.8%, respectively.
Furthermore, median overall survival for responding patients at the
1.5 mg/kg dose (n=9) was 21.8 months, with 1-year, 2-year and
3-year survival rates of 66.7%, 44.4% and 44.4%, respectively.
Responding patients also demonstrated a statistically significant
mean 6.3-fold increase (p=0.003) in the number of AML blasts in the
peripheral blood following BL-8040 monotherapy treatment, whereas
in non-responding patients the mean-fold increase was minor and
non-significant (1.66-fold; p=0.21).
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 and immune-cells from
the bone marrow, thereby sensitizing cancer 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 mobilization of other cell types,
including the mobilization of hematopoietic stem and progenitor
cells, T, B, NK and antigen presenting cells. 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
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 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 is expected to initiate a first-in-man study in mid-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 is carrying out 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
Tsipi Haitovsky
Public Relations
+972-52-598-9892
tsipihai5@gmail.com
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SOURCE BioLineRx Ltd.