08 June 2022 – Race Oncology Limited (“Race”) is pleased to announce it is expanding the FTO-targeted BISECT (RAC-006) clinical trial in extramedullary Acute Myeloid Leukaemia (EMD AML) and Myelodysplastic Syndromes (MDS) to include five additional trial sites in Spain and Italy and has signed a new clinical support agreement with global Clinical Research Organisation, Parexel International to support the additional trial monitoring activities.
BISECT (RAC-006) is an open label Phase 1b/2a clinical trial in patients with EMD AML and MDS which recently received Ethics and Governance approval to commence patient recruitment at the Calvary Mater Hospital Newcastle (ASX announcements: 6 April 2022 and 12 May 2022). The intention to expand the BISECT trial to Europe was announced at the 2021 Race Annual General Meeting (ASX Announcement: 23 November 2021).
“We are pleased that we have received strong interest in our BISECT (RAC-006) EMD AML and MDS study from experienced European haematologists. These clinicians identify a significant unmet need for the treatment of EMD AML and MDS and want to be actively involved in EMD clinical research. We look forward to activating these sites once we have cleared the necessary European Regulatory and Ethics approval process.”Race CMO Dr David Fuller
The total study costs are expected to be in the range of A$7.7 million to a maximum of A$15.4 million. The final cost is dependent on the location and number of patients screened and enrolled in the trial. Due to the adaptive (Bayesian) design of this study, the total study costs cannot be precisely determined, but are expected to be lower than the maximum cited here.
Payments will be made to Parexel throughout the study upon reaching key milestones as patients are recruited and other operational variables are achieved.
“This study supports our Pillar 1 FDA registration ambitions and builds on Zantrene’s historical safety and efficacy in AML. The clinical use of Zantrene using superior drug combinations offers hope to patients with difficult to treat forms of AML and MDS.”Race CEO & MD Phillip Lynch