Date: 2014-12-12
Type of information: Initiation of development program
phase: 1-2
Announcement: initiation of the development program
Company: BioLineRx (Israel)
Product: BL-8040
Action
mechanism: peptide. BL-8040 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. BL-8040 has been shown to induce the mobilization of healthy hematopoietic stem cells from the bone marrow into the peripheral blood. BL-8040 also mobilizes cancer cells from the bone marrow and other sites and may therefore expose these cells to chemo- and bio-based anti-cancer therapy and induce apoptosis (cell death). Pre-clinical studies show that BL-8040 is efficient, both alone and in combination with the anti-cancer drug rituximab, in reducing bone marrow metastasis of lymphoma cells and stimulating lymphoma cell death.
Disease: hypoplastic myelodysplastic syndrome (hMDS)
aplastic anemia (AA)
Therapeutic area: Cancer - Oncology
Country: USA
Trial details:
Latest
news: * On September 10, 2015, BioLineRx announced that it has filed the regulatory submissions required to commence a Phase 2 trial for BL-8040, in combination with standard-of-care immunosuppressive therapy, as a novel treatment for two bone marrow failure conditions: hypoplastic myelodysplastic syndrome (hMDS) and aplastic anemia (AA). The trial is expected to commence shortly after receipt of regulatory approval, anticipated in the next few months. The open-label Phase 2 trial will be conducted in collaboration with MD Anderson Cancer Center in Houston and is expected to enroll up to 25 patients. The study will examine BL-8040’s ability to improve bone marrow cellularity and peripheral blood counts in patients suffering from these bone marrow failure conditions. * On December 12, 2014, During an investor and analyst meeting hosted in New York, BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, will disclose its multi-year development plan for BL-8040, a unique platform for the treatment of hematological cancers. The main development program for BL-8040 relates to acute myeloid leukemia (AML). BL-8040 is currently undergoing a Phase 2a clinical trial for the treatment of relapsed or refractory AML. A second clinical development program planned for BL-8040 designates the drug for the treatment of hypoplastic myelodysplastic syndrome (hMDS) and aplastic anemia (AA). Preclinical data suggest that BL-8040 promotes stem cell proliferation and differentiation thereby allowing recovery of hematopoiesis (formation and development of blood cells). The data show that treatment of mice with BL-8040 contributes to bone marrow regeneration, and increases the number of progenitor cells and the mature components of the blood and immune systems. BioLineRx is planning to commence a Phase 1/2 trial, to assess the addition of BL-8040 to the standard immunosuppressive therapy in patients with hMDS or AA, in the second quarter of 2015. This trial will be conducted in collaboration with the MD Anderson Cancer Center.
