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biolinerx ltd (BLRX) Details

BioLineRx Ltd., a clinical stage biopharmaceutical development company, is engaged in identifying, in-licensing, and developing therapeutic candidates that address unmet medical needs. The company’s development pipeline consists of clinical-stage therapeutic candidates, including BL-1040, a resorbable polymer solution being developed to reduce or prevent the ventricular remodeling; BL-8040, a peptide for the treatment of acute myeloid leukemia, stem cell mobilization, and other hematological indications; BL-7010, a polymer for the treatment of celiac disease; BL-5010, which is being developed as a medical device for the non-surgical removal of benign skin lesions; BL-7040, an oligonucleotide for the treatment of inflammatory bowel disease; and BL-8020, an orally available treatment for the Hepatitis C virus and other viral indications. It also has three therapeutic candidates in the preclinical stages of development, such as BL-8030 for the treatment of Hepatitis C; BL-9010 to treat severe allergies/asthma; and BL-9020 for the treatment of type 1 diabetes. BioLineRx Ltd. was founded in 2003 and is headquartered in Jerusalem, Israel.

43 Employees
Last Reported Date: 03/17/14
Founded in 2003

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biolinerx ltd (BLRX) Key Developments

BioLineRx Ltd. Announces Preclinical Results of BL-8040 Cancer Therapy Platform

BioLineRx Ltd. announced the presentation of positive preclinical results of its BL-8040 cancer therapy platform, as a novel treatment for a sub-population of acute myeloid leukemia (AML patients with FLT3 mutations), at the Society of Hematologic Oncology (SOHO) 2014 Annual Meeting in Houston, Texas. The data show that BL-8040 synergizes with another AML drug in development, the FLT3 inhibitor AC220, to reduce minimal levels of residual disease in the bone marrow of an AML mice model with the FLT3-ITD-mutation. BL-8040 is a novel, potent and selective inhibitor of the CXCR4 chemokine receptor, which is normally activated by the chemokine ligand CXCL12. Both CXCL12 and its receptor, CXCR4, are key players in enabling AML cancer cells to hide and thrive in the bone marrow, with CXCR4 expression in AML patients being associated with a poor prognosis. FLT3 mutations are detected in approximately 30% of AML cases and are associated with a poor prognosis and high incidence of relapse in AML patients. FLT3 mutations have also been shown to activate CXCR4 signaling and are associated with increased CXCR4 expression. It is believed that inhibition of CXCR4 may sensitize AML cells to chemotherapy and FLT-3 targeted therapies. The data presented during the conference show that BL-8040 rapidly and efficiently induces cell death of AML cells both in-vitro and in-vivo. Additionally, the combination of BL-8040 with the FLT3 inhibitor AC220 (Quizartinib) in-vitro increased the apoptotic effect of AC220, from a 60% reduction to a 97% reduction in AML cell viability. In-vivo, BL-8040 also augmented the effect of AC220, reducing the level of residual AML cancer cells in the bone marrow from 0.05% to as low as 0.006%, eliminating the disease altogether in some mice from this treatment group. Importantly, reduction of the disease burden in the BL-8040 and AC220 combination therapy group resulted in prolonged survival. Furthermore, the addition of BL-8040 in the combination therapy group also mitigated the reduction in normal white blood cells observed when administering the AC220 treatment on a stand-alone basis. BL-8040 is currently undergoing a Phase 2 clinical trial in adult AML patients with relapsed or refractory AML, the results of which are expected in early 2015. Concurrently, a Phase 1 stem cell mobilization study for BL-8040 is ongoing, with results expected by the end of 2014 or the beginning of 2015; and an investigator-led Phase 1/2 study for BL-8040 in Chronic Myeloid Leukemia (CML) is expected to commence in 2014.

BioLineRx, Ltd. - Special Call

To consider the positive preclinical results of its BL-8040 cancer therapy platform

BioLineRx, Ltd. Announces Dosing of First Patient in Phase 1 Trial for Second Indication of BL-8040 Cancer Therapy Platform

BioLineRx, Ltd. announced the dosing of the first patient in a Phase 1 trial for a second indication of its BL-8040 cancer therapy platform, as a novel treatment for the mobilization of stem cells from the bone marrow to the peripheral blood circulation, where they can be harvested for transplant supporting the treatment of hematological indications. 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.


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