|BioLineRx Doses First Patient for BL-8040’s Second Indication as Novel Stem Cell Mobilization Treatment|
Results from Phase 1 trial expected by end of 2014 or early 2015; BL-8040 also in midst of Phase 2 trial for AML, with results expected in early 2015
“Stem cell mobilization is used more and more as a method of collecting
hematopoietic stem cells for transplantation, which is used to treat
certain types of cancer such as myeloma, leukemia or lymphoma, as well
as for the treatment of severe anemia or immune deficiency disorders.
Traditionally, these cells were harvested from the bone marrow using a
surgical procedure, which involves general anesthesia. Current treatment
regimens involve daily injections for 4-6 days of G-CSF, with or without
the addition of a mobilizing agent such as Plerixafor (Mozobil). BL-8040
given as a single injection was previously shown in a Phase 1/2 study in
multiple myeloma patients to be highly effective in mobilizing stem
cells in combination with G-CSF injections. Although it is a Phase 1
study, the current trial will provide us with efficacy data regarding
the mobilization capacity of one or two injections of BL-8040 as a
stand-alone therapy, which could significantly shorten and reduce the
cost of treatment, as well as eliminate the painful side effects
associated with G-CSF,” explained Dr.
The stem cell mobilization Phase 1 study consists of two parts. Part 1 is a randomized, double-blind, placebo-controlled dose escalation study exploring the safety and tolerability of escalating repeated doses of BL-8040 in healthy volunteers. Secondary objectives include assessment of the efficacy of BL-8040 in mobilizing stem cells as a stand-alone therapy, as well as determining the pharmacokinetic profile of the drug. This part will be performed in up to 4 cohorts, with 8 healthy volunteers in each cohort. Part 1 of the study will serve to select the optimal safe and efficacious dose of BL-8040 to be used as a stand-alone therapy in Part 2 of the study.
Part 2 is an open-label study designed to assess BL-8040’s stem cell mobilization capacity, as well as the yield of cells collected by apheresis. Secondary endpoints of the study include evaluation of the viability and biological activity of cells mobilized by BL-8040 and collected by apheresis. This part will be performed in a single cohort of 8 healthy volunteers who will receive the selected dose regimen of BL-8040 based on the data from Part 1.
About Stem Cell Mobilization
BL-8040 also mobilizes stem cells from the bone marrow to the peripheral blood, enabling their collection for subsequent autologous or allogeneic transplantation in cancer patients. In a Phase 1/2, open-label, dose escalation, safety and efficacy clinical trial in 18 multiple myeloma patients, BL-8040 demonstrated an excellent safety profile at all doses tested and was highly effective in combination with G-CSF in the mobilization of hematopoietic stem cells and white blood cells from the bone marrow to the peripheral blood. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.
BioLineRx’s current portfolio consists of a variety of clinical and
pre-clinical projects, including: BL-1040 for prevention of pathological
cardiac remodeling following a myocardial infarction, which has been
out-licensed to Bellerophon BCM (f/k/a
For more information on BioLineRx, please visit www.biolinerx.com
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access to the Company’s
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
Tiberend Strategic Advisors, Inc.