- Race Oncology (RAC) receives human ethics approval for its clinical trial of Zantrene in patients with acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS)
- Before patients can be enrolled and treated at the lead site, Race must receive Research Governance Office (RGO) approval which is expected in four to eight weeks
- The trial will recruit up to 60 patients with AML or MDS with the primary endpoint of complete response and the secondary endpoint of the confirmation of the safety and tolerability of Zantrene
- The trial is expected to take between 36 to 40 months to complete with treatment to begin once approval is obtained
- Race ends the day a slight 0.72 per cent in the red with shares trading at $2.75
Race Oncology (RAC) has received human ethics approval for its clinical trial of Zantrene in patients with acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS).
Before patients can be enrolled and treated at the lead site – Calvary Mater Newcastle Hospital – Race must receive Research Governance Office (RGO) approval.
All required documents have been submitted with approval expected within four to eight weeks.
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.
“We are pleased to receive this first human ethics approval and expect to expand the study to more approved Australian sites in the coming months,” Chief Medical Officer Dr David Fuller said.
“In addition, based on positive feedback from European clinical key opinion leaders and
supported by the proceeds of our recent share purchase plan, we look forward to adding
additional trial sites in Europe.”
Race has ended the day a slight 0.72 per cent in the red with shares trading at $2.75.