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Highlights
- Race Oncology expands its clinical trial in EMD AML and MDS across five new sites in Europe
- The study supports the Pillar 3 FDA registration ambitions and builds on Zantrene’s historical safety and efficacy in AML
- The clinical trial will recruit 60 patients at 10 clinical sites
Race Oncology Limited (ASX:RAC) shares gained over 3% to AU$1.690 on 8 June 2022 post an upbeat update concerning a clinical study.
The company is expanding the FTO-targeted BISECT (RAC-006) clinical trial in extramedullary Acute Myeloid Leukaemia (EMD AML) and Myelodysplastic Syndromes (MDS) with five new sites across Spain and Italy.
Further, to monitor the trial activities, the company has signed a new clinical support agreement with global Clinical Research Organisation, Parexel International.
According to Race CEO & MD Phillip Lynch, the study supports the Pillar 3 FDA registration ambitions and builds on Zantrene’s historical safety and efficacy in AML.
Overall cost of the study is expected to range between AU$7.7 million and AU$15.4 million, depending on the location and number of patients screened and enrolled in the trial.
About the trial
BISECT (RAC-006) is an open-label Phase 1b/2a clinical trial in EMD AML and MDS patients. It will recruit 60 patients at 10 clinical sites and will use a two-stratum (arm) design.
Image source: © 2022 Kalkine Media®, data: company update
Key secondary endpoints – Safety and tolerability of Zantrene, overall and event-free survival, and the correlation of FTO expression or other biomarkers with response to treatment.
Strong interest from European haematologists
Race has gained significant interest from experienced European haematologists in its study. Moreover, these haematologists want to be actively engaged in clinical research concerning EMD.
The new sites will be activated after completing the required European Regulatory and Ethics approval process.
