- Race Oncology (RAC) will collaborate with The University of Newcastle on a preclinical research program focussed on extramedullary acute myeloid leukaemia (AML)
- The program will assess the potential of the company’s drug Bisantrene to treat this form of AML, which, at present, has only limited experimental treatment options available
- The study in rats will provide data to support a pivotal phase II/III trial of Bisantrene with the aim of paving the way for U.S. FDA orphan drug designation
- It follows a phase two clinical trial completed last year, which found the treatment to be highly effective in patients with extramedullary AML
- RAC shares have dipped 0.5 per cent to trade at $3.82
Race Oncology (RAC) will collaborate with The University of Newcastle on a preclinical research program focused on extramedullary acute myeloid leukaemia (AML).
The program will assess the potential of Race Oncology’s drug Bisantrene to treat this form of AML and will be led by Associate Professor Nikki Verrills, who ran the company’s preclinical breast and ovarian program.
AML occurs when leukaemia spreads from bone marrow and forms tumours in other tissue such as the skin, brain, breast or kidney. A 2020 imaging trial found 22 per cent of AML patients also have extramedullary AML, however, at present, there are only limited experimental treatments available.
The upcoming preclinical study will use a rat-based model and will provide data to support a pivotal phase II/III trial of Bisantrene. Race Oncology hopes the pivotal trial will pave the way for Bisantrene to obtain orphan drug designation from the U.S. Food and Drug Administration.
The collaborative research program follows a Sheba Medical Centre phase II clinical trial completed last year in patients with relapsed or refractory AML. It demonstrated Bisantrene to be highly effective at treating patients with extramedullary AML.
“Recent clinical evidence has identified Bisantrene as an effective treatment option for patients with the difficult-to-treat extramedullary form of AML,” said Race Oncology Chief Scientific Officer Dr Daniel Tillett.
“We believe that we have identified a low-risk pathway to rapid approval of Bisantrene via this indication that offers significant upside for Race in a crowded clinical space.”
Race Oncology and The University of Newcastle will get started straight away and expect to report preclinical results over the next 12 months.
RAC shares have dipped 0.5 per cent to trade at $3.82 at 10:24 am.