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news.BioLineRx has filed the regulatory submissions to start phase 2 trial of BL-8040 as novel treatment for hypoplastic myelodysplastic syndrome and aplastic anemia.
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The company will undertake the open-label Phase 2 trial in collaboration with MD Anderson Cancer Center in Houston.
About 25 patients are expected to be enrolled in the study, which will evaluate BL-8040’s ability to enhance bone marrow cellularity and peripheral blood counts in patients suffering from the bone marrow failure conditions, hypoplastic myelodysplastic syndrome (hMDS) and aplastic anemia (AA).
BioLineRx said both hMDS and AA are characterized by a T cell-driven autoimmune attack on the bone marrow, leading to depletion of hematopoietic precursors, resulting in anemia and low white blood cell counts.
Preclinical studies in mice revealed that several doses of BL-8040 resulted in a marked increase in the number of hematopoietic progenitor cells and hematopoietic stem cells in the bone marrow and peripheral blood.
BioLineRx CEO Kinneret Savitsky said: "The hMDS/AA trial will assess BL-8040 in combination with standard of care immunosuppressive therapy, with interim results expected by the end of 2016.
"Both hMDS and AA represent significant unmet medical needs and we are very hopeful that BL-8040, as part of a novel treatment regimen, will significantly improve bone marrow cellularity and peripheral blood counts in patients suffering from these difficult bone marrow failure conditions."
Under a Phase 1/2, open-label, dose escalation, safety and efficacy clinical trial in 18 multiple myeloma patients, BL-8040, when combined with G-CSF, showed a better safety profile at all doses tested.
It was effective in the mobilization of hematopoietic stem cells and white blood cells from the bone marrow to the peripheral blood.