- Race Oncology is riding high with governance approval for human trial of its new therapy Zantrene®.
- The cancer drug will be studied in patients with extramedullary Acute Myeloid Leukaemia (AML) or high-risk Myelodysplastic Syndrome (MDS).
- The open label Phase 1 trial will be performed at trial sites in Australia and Europe.
- The trial is likely to take 36 to 40 months.
Precision oncology company Race Oncology Limited (ASX: RAC) has hit a major milestone with governance approval for an open label clinical trial of Zantrene® in patients with extramedullary AML or high-risk MDS.
Zantrene® is a Phase 2/3 cancer drug that RAC is exploring as a new therapy for melanoma and clear cell renal cell carcinoma, a potent inhibitor of the Fatso/Fat mass (FFM) and obesity associated (FTO) protein.
RGO approval for Zantrene® open label clinical trial
The company received Research Governance Office (RGO) approval from the Calvary Mater Newcastle Hospital for the clinical trial, which will recruit up to 60 patients with extramedullary AML or MDS using a two-stratum (arm) design.
As per the company, this is the first clinical trial in the world to investigate the targeting of FTO as a potential cancer therapy using an AML & MDS population.
The open label Phase 1 trial with a dose expansion Phase 2 stage will occur in Australia and Europe. Recruitment of the first patient will be done after completing a site training, which will involve representatives of the Race Oncology clinical team, contract research organisation Paraxel, and associated clinical teams of Calvary Mater Hospital.
Data source: Company update
Details of the clinical trial
The trial will take 36 to 40 months and will recruit nearly 60 patients, with full patient recruitment expected to complete in approximately 18 months. As the trial is open label in nature, patient outcome results are obtained soon after patients are treated.
The trial will include two stratums
First stratum – Use Zantrene as a high dose, single-agent treatment over seven days in patients with extramedullary AML who can tolerate high-intensity chemotherapy. This will be followed by one or more cycles of consolidation treatment using Zantrene in combination with AraC, a standard of care AML drug. The clinical aim will be bridging the patient to an allogeneic hematopoietic stem cell transplant.
Second stratum – Use Zantrene as a low dose FTO-targeted agent in combination with the oral hypomethylating agent, ASTX727, for MDS or AML patients unwilling, or unable to tolerate high intensity chemotherapy. The clinical aim will be the safety and tolerability of the decitabine/Zantrene regime.
At the time of writing this article (THU 12 MAY 11:04 AM AEST), shares of RAC were trading at AU$2.000.