Race Oncology Ltd (ASX:RAC, OTC:RAONF) welcomes results from an investigator-sponsored Phase 1b/2 trial of RC110 bisantrene for the treatment of acute myeloid leukaemia (AML), which exceeded the predetermined efficacy threshold with a 40% response rate.
The open-label trial tested intravenous (IV) RC110 bisantrene in combination with chemotherapies clofarabine and fludarabine in patients with relapsed (cancer returns) or refractory (unresponsive to treatment) AML.
In patients with highly advanced disease, 40% showed a response to the combination treatment. Five experienced complete responses and one a partial response, surpassing the efficacy goal of at least three complete responses.
Strong evidence, increased interest
“I would like to extend my sincere thanks to Professor Nagler and his dedicated team at the Chaim Sheba Medical Centre, who have spent the last five years meticulously investigating the utility of bisantrene for patients with relapsed/refractory Acute Myeloid Leukaemia,” Race Oncology CEO Dr Daniel Tillett said.
“The Sheba team’s dedication and commitment have added to the strong historical evidence of bisantrene’s efficacy in treating patients with AML and has stimulated further clinician interest in taking the drug forward in new AML trials.
“We extend our gratitude to all patients and their families whose participation makes the development of new AML treatments such as bisantrene possible.”
RAC says the highly positive findings from the trial strongly support the company’s plans to begin a new Phase 1/2 investigator-sponsored AML trial using RC220 bisantrene.
Race is advancing a reformulated bisantrene (RC220) to address the high unmet needs of patients across multiple oncology indications.
The company is clinically focused on anthracycline combinations, where RAC hopes to deliver cardio-protection and enhanced anticancer activity in solid tumours, as well as a low-intensity treatment for acute myeloid leukaemia.