On April 6, 2022 Race Oncology Limited ("Race") reported it has received human ethics approval for its open label clinical trial of Zantrene (bisantrene dihydrochloride) in patients with extramedullary Acute Myeloid Leukaemia (AML) or highrisk Myelodysplastic Syndrome (MDS) (Press release, Race Oncology, APR 6, 2022, View Source [SID1234613997]).
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Before patients can be enrolled and treated at the lead site – Calvary Mater Newcastle Hospital – Race must receive Research Governance Office (RGO) (site budget and contracting) approval. All required documentation has now been submitted to enable this outcome. Governance approval is typically received within 4 to 8 weeks from submission.
This open label Phase 1 trial with a dose expansion Phase 2 stage will recruit up to 60 patients with extramedullary AML or MDS using a two-stratum (arm) design (ASX Announcement: November 1, 2021).