6 April 2022 – Race Oncology Limited (“Race”) is pleased to announce 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).
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).