- Race Oncology (RAC) has chosen contract research organisation Parexel International to support its Acute Myeloid Leukemia (AML) clinical trial
- The trial is testing Race’s Bisantrene in AML patients with extramedullary disease
- The study will be led by Principal Investigator Associate Professor Anoop Enjet and is expected to take 36 to 40 months to complete
- The aim of the trial is to achieve orphan drug approval for Bisantrene
- Race is trading up 3.63 per cent at $3.71 per share
Race Oncology (RAC) has chosen contract research organisation Parexel International to support its Acute Myeloid Leukemia (AML) clinical trial.
The phase 1/2 trial of Race’s Bisantrene will be conducted in AML patients with extramedullary disease.
Extramedullary AML occurs when leukaemia spreads from the bone marrow and forms solid tumours in tissues such as the skin, breast, kidney, brain or other organs.
The study will be led by Principal Investigator Associate Professor Anoop Enjet, who is a highly experienced haematologist having led more than 25 clinical trials.
The trial will recruit around 60 patients across 10 clinical sites in Australia and is expected to take 36 to 40 months to complete.
Under the agreement, Race will pay Parexel an initial fee of $1.1 million under start-up agreement. Further payments will be made under the master service agreement once the study reaches certain milestones.
The aim of the trial is to achieve orphan drug approval for Bisantrene and the first patient is expected to be treated at the end of the year.
“This study supports our Pillar 3 registration ambition to see Bisantrene’s historical safety and efficacy in AML demonstrated with superior drug
combinations that may benefit patients who remain challenged by initial treatment failures,” CEO Phillip Lynch said.
Race is trading up 3.63 per cent at $3.71 per share at 11.25am AEST.