- Race Oncology (RAC) receives governance approval for a clinical trial of Zantrene in patients with acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS)
- Together with ethics approval and completion of site training due to start May 31, patients will be enrolled and treated at the Calvary Mater Newcastle Hospital, the trial’s lead site
- Interestingly, this is the first clinical trial in the world to investigate the targeting of FTO as a potential cancer therapy using an AML and MDS population
- The first patient is expected to be recruited soon after site initiation with patient results obtained soon after treatment which the company said it will publish once available
- RAC shares are up a slight 0.5 per cent, trading at $2
Race Oncology (RAC) has received Research Governance Office (RSO) approval for its clinical trial of Zantrene in patients with acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS).
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 May 31.
Together with ethics approval and completion of site training, patients will be enrolled and treated at the Calvary Mater Newcastle Hospital, the lead site of the trial.
The open-label trial will recruit up to 60 patients with extramedullary AML or MDS with the primary endpoint of complete response and complete response with incomplete haematological recovery.
Secondary endpoints include the safety and tolerability of Zantrene and overall and event-free survival.
The trial is expected to take between 36 to 40 months to complete with treatment to begin once approval is obtained.
Extramedullary AML occurs when leukaemia spreads from the bone marrow and forms solid tumours in tissues such as the skin, breast, brain and kidneys.
Currently, there are no approved treatments for individuals with extramedullary AML as it is difficult to treat.
MDS are a group of blood cancers that affect the production of normal blood cells in the bone marrow.
This includes chronic myelomonocytic leukaemia, atypical chronic myeloid leukaemia and myelodysplastic/myeloproliferative neoplasms unclassifiable.
The first patient is expected to be recruited soon after site initiation and because it is an open-label trial, patient results will be obtained soon after treatment which the company said it will update as soon as that becomes available.
RAC shares were up a slight 0.5 per cent, trading at $2 as of 11:30 am AEST.