Faron Pharma gets US FDA & FIMEA approvals to begin phase I/II bexmarilimab combination study in hematologic malignancies
Faron Pharmaceuticals Ltd., a clinical stage biopharmaceutical company, announces that both the US Food and Drug Administration (FDA) and Finnish Medicines Agency (FIMEA) have cleared Faron's Investigational New Drug (IND) application to begin the company sponsored BEXMAB study. BEXMAB is a novel phase I/II study to assess safety, tolerability and preliminary efficacy of bexmarilimab, Faron's wholly-owned investigational precision cancer immunotherapy, in combination with standard of care (SoC) therapy in patients with relapsed acute myeloid leukaemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukaemia (CML). This marks the first time bexmarilimab will be assessed as part of a clinical study in hematologic malignancies.
"We are pleased that our IND application was cleared to proceed, and we can further explore the strong scientific rationale for combining bexmarilimab and azacitidine," said Marie-Louise Fj
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