Race Oncology completes GLP studies for RC220 bisantrene; closer to human trials

Proactive - Interviews for investors

Race Oncology Ltd (ASX:RAC) CEO Dr Daniel Tillett joins Proactive’s Jonathan Jackson following the completion of Good Laboratory Practice (GLP) toxicology and safety pharmacology studies for RC220 bisantrene, its flagship formulation for peripheral intravenous (IV) infusion. These studies, contracted to Attentive Science (USA) and Agilex Biolabs (Australia) in October 2023, found no unexpected toxicities and support the use of RC220 bisantrene in human clinical trials. The GLP studies, conducted on time and within budget, aimed to confirm the safety of RC220 bisantrene in two animal species and establish a starting dose for Phase I clinical trials. Three doses (low, medium and high) were administered via peripheral veins, showing systemic effects similar to those of the historical bisantrene formulation administered centrally. Observed toxicities were reversible post a four-week recovery period, with no adverse infusion site or vein reactions specific to RC220. Safety pharmacology studies confirmed an acceptable respiratory and cardiovascular safety profile at all dose levels. The data will support regulatory submissions for human clinical trials, including a 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. Tillett praised the team for completing the studies efficiently and highlighted the significance of these findings in advancing RC220 bisantrene towards clinical use. The next steps involve submitting a human ethics application in Q3 CY2024, followed by clinical site governance approval and anticipated patient recruitment in Q4 CY2024. #ProactiveInvestors #RaceOncology #ASX #RC220Bisantrene, #GLPStudies, #ClinicalTrials, #CancerResearch, #Oncology, #Pharmacology, #DrugSafety, #Toxicology, #PeripheralIVInfusion, #ClinicalDevelopment, #Phase1Trials, #HealthcareInnovation, #Biotech, #MedicalResearch, #CancerTreatment, #DrugDevelopment, #FDA, #PreclinicalStudies, #Pharmaceuticals #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews