Good Laboratory Practice (GLP) toxicology and safety pharmacology studies of the flagship RC220 bisantrene formulation of Race Oncology Ltd (ASX:RAC, OTC:RAONF) have been wrapped up on time and on budget.
"Excellent safety profile"
Attentive Science and Agilex Biolabs conducted the preclinical studies, which confirm that RC220 bisantrene has an "excellent safety profile" for a chemotherapeutic oncology drug, including when administered via peripheral intravenous infusion.
These studies observed ‘no unexpected or unacceptable toxicities’.
The complete data package supports the start of human clinical trials using RC220 bisantrene in the second half of this year, with a US Food and Drug Administration (FDA) investigational new drug (IND) application to follow in 2025.
The studies aimed to:
- demonstrate in two animal species that RC220 bisantrene is safe and amenable to administration via peripheral IV infusion in humans; and
- establish an acceptable starting dose for Phase I clinical studies.
During the studies, three doses of RC220 bisantrene – low, medium and high, reflecting the expected dose-range in humans – were administered via peripheral veins and showed similar systemic effects to those seen when using the historical bisantrene formulation administered via a central line.
Examination of the animals after a four-week post-dose recovery period showed that all observed toxicities were reversible.
Importantly, there were no RC220 formulation-specific adverse macroscopic or histological findings at the sites of infusion.
This finding confirmed that, unlike the historical bisantrene formulation, peripheral IV administration of RC220 bisantrene was devoid of adverse infusion site or vein reactions.
Safety pharmacology studies also confirmed that at all three dose levels evaluated, RC220 bisantrene had an acceptable respiratory and cardiovascular safety profile.
Data will support human trials
Data from these studies will be used to support regulatory and ethics submissions for evaluation of RC220 bisantrene in human clinical trials, including the upcoming Phase 1a/1b trial in Australia, Hong Kong and South Korea, an investigator-sponsored Phase 1/2 AML trial and a US FDA IND application in 2025.
Race CEO Dr Daniel Tillett said: “Receiving clear confirmation of the safety of RC220 bisantrene in these studies and identifying a suitable starting dose for our upcoming trial is another major milestone in bringing our new drug product to cancer patients.
“I congratulate and thank the Race preclinical team, Attentive Science and Agilex Biolabs for completing these studies on time and on-budget.”
The next step in the process will be submission of the human ethics application in the third quarter of this year. Once that has been received, the company will garner clinical site governance approval.
Assuming all the regulatory bodies process the paperwork efficiently, the company expects to recruit the first patients in the trial late in the fourth quarter of 2024.