On May 12, 2022 Race Oncology Limited ("Race") reported it has received Research Governance Office (RGO) approval from the Calvary Mater Newcastle Hospital for its open label clinical trial of Zantrene (bisantrene dihydrochloride) in patients with extramedullary Acute Myeloid Leukaemia (AML) or high-risk Myelodysplastic Syndrome (MDS). Human ethics approval for this trial has been granted (ASX Announcement: 5 April 2022) (Press release, Race Oncology, MAY 12, 2022, View Source [SID1234614468]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Representatives of the Race Oncology clinical team, the contract research organisation Paraxel, and associated clinical teams of the Calvary Mater Hospital are scheduled to meet for site initiation and training on the May 31, 2022. Completion of this site training will enable the first patient to be recruited into the trial.
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 at trial sites in Australia and Europe (ASX Announcement: November 1, 2021).