|BioLineRx Announces Investigator-Initiated Study for Novel Chronic Myeloid Leukemia Treatment|
Phase 1/2 study will assess effect of BL-8040 in combination with standard therapy
CML is a cancer of white blood cells that is driven by a constitutively active oncogenic tyrosine kinase. The main treatment today is with tyrosine kinase inhibitors, such as Imatinib (Gleevec), but about 15% of patients do not have an optimal response to the drug, and 40% eventually develop resistance to the drug. In addition, treatment with Gleevec does not always prevent recurrence of the disease, presumably due to the survival of dormant, tumorigenic stem cells in the bone marrow.
The study is designed as a Phase 1/2, randomized, dose-escalation study
to assess the combination of BL-8040 with standard-of-care Imatinib for
improving the response of CML patients in the first chronic phase of the
disease who have achieved a less than optimal response with Imatinib
alone. Primary endpoints of the study are the safety and tolerability of
BL-8040 in combination with Imatinib, and the secondary endpoints
include assessing the efficacy of the combination therapy in achieving
improved cytogenetic and molecular response in CML patients. The study
will be performed at the
“The bone marrow has a protective effect on CML stem cells, and enables them to evade eradication by existing drugs. Preclinical data have shown that BL-8040 efficiently synergizes with Imatinib in-vitro1 and in-vivo, overcoming the protective effect of the bone marrow, and we therefore hope that the combination of these two drugs will override drug resistance and suppress residual disease," stated Prof. Nagler. "It is conceivable that adding BL-8040 to Imatinib therapy in CML patients who have not achieved optimal cytogenetic or molecular responses may improve their response to Imatinib by directly inducing apoptosis of the tumor cells and by mobilizing leukemic stem cells from the bone marrow’s protective niches and sensitizing them to Imatinib-induced cell death.”
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
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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
of Imatinib with CXCR4 antagonist BKT140 overcomes the protective effect
of stroma and targets CML in vitro and in vivo.
Tiberend Strategic Advisors, Inc.