|BioLineRx Announces Regulatory Submission for Phase 2b Trial for Novel AML Consolidation Treatment|
- BL-8040 Phase 2b study, as consolidation treatment for AML patients responding to standard induction treatment, is expected to commence shortly after receipt of regulatory approval, anticipated in next few months -
The Phase 2b trial is a double-blind, placebo-controlled, randomized,
multi-center study conducted in collaboration with the
“Furthermore, BL-8040 has several unique mechanisms of action that enable it to positively affect various aspects of bone marrow function, both relating to healthy stem cells as well as to cancer cells. The breadth of BL-8040’s potential is reflected in the comprehensive development plan we have established for this compound. We look forward to initiating this Phase 2b trial as well as our other planned studies for 2015, and to advancing this promising treatment platform for multiple hematological indications,” concluded Dr. Savitsky.
BL-8040 is a clinical-stage drug candidate for the treatment of acute myeloid leukemia, as well as other hematological indications. It is a short peptide that functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis (growth of new blood vessels in the tumor), metastasis (spread of the disease to other organs or organ parts) and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. 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 the mobilization of hematopoietic stem cells and white blood cells from the bone marrow to the peripheral blood.
BL-8040 also mobilizes cancer cells from the bone marrow and may
therefore sensitize these cells to chemo- and bio-based anti-cancer
therapy. Importantly, BL-8040 has also demonstrated a direct anti-cancer
effect by inducing apoptosis. Pre-clinical studies show that BL-8040
inhibits the growth of various tumor types, including multiple myeloma,
non-Hodgkin's lymphoma, leukemia, non-small cell lung carcinoma,
neuroblastoma and melanoma. In these studies, BL-8040 significantly and
preferentially stimulated apoptotic cell death of malignant cells
(multiple myeloma, non-Hodgkin's lymphoma and leukemia). Significant
synergistic and/or additive tumor cell killing activity has also been
observed in-vitro and in-vivo when tumor cells were treated with BL-8040
together with Rituximab, Bortezomib, Imatinib, Cytarabine and the FLT-3
inhibitor AC-220 (in
About Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most common type of acute leukemia in adults. According to the American Cancer Society, approximately 14,500 new cases of AML were diagnosed in the United States in 2013, and the median age of AML patients was 66 years old. AML is usually treated in two phases - the induction and consolidation phases. Induction treatment is aimed at eradicating all visible leukemic cells, resulting in initial remission, while consolidation treatment is aimed at destroying any remaining leukemic cells. The median survival for patients receiving induction chemotherapy, which is associated with high mortality, is 6-12 months, with shorter survival for patients over the age of 60 or for those with certain gene or chromosome aberrations. The five-year survival rate for AML is 10-30 percent, due to relapsed or refractory disease associated with standard treatments.
BioLineRx is a publicly-traded, clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates. The Company in-licenses novel compounds primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.
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 or download the investor relations mobile device app, which allows users access to the Company’s SEC documents, press releases, and events. BioLineRx’s IR app is available on the iTunes App Store as well as the Google Play Store.
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 the Securities and Exchange Commission on March 17, 2014. 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.
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