Race Oncology Ltd (ASX:RAC) has initiated toxicology and safety pharmacology studies that are required to support human clinical trials of its flagship bisantrene formulation for peripheral infusion, RC220.
Contracts signed
The company has signed contracts with Attentive Science (USA) and Agilex Biolabs (Australia) to complete a package of Good Laboratory Practice (GLP) toxicology and safety pharmacology studies of RC220.
The studies are set to commence immediately, with final reporting expected mid next year. The total cost is A$2.74 million, with most expenses expected to be eligible for the Australian Taxation Office R&D tax incentive of 43.5%.
Race executive director Dr Pete Smith said: “These critical studies represent a significant milestone for Race and the clinical and commercial development of RC220 by establishing bisantrene’s known safety profile in its new formulation.
“Attentive Science and Agilex Biolabs are impressive and complementary organisations, each specialising in the different aspects of the required work. We are confident that in executing these studies they will meet our high expectations in terms of time, cost and quality.”
A view towards RC220 human trials
While extensive historical and modern clinical data has been collected around the safety and efficacy of bisantrene in humans, all new drug products must pass a panel of toxicology and safety pharmacology preclinical studies.
RC220 is considered a new ‘drug product’ — even though it contains the same active pharmaceutical ingredient (API) as previous formulations, it is a new formulation of bisantrene that will enable safer and more patient friendly peripheral infusions.
The studies are required to show the infusions are safe for use in humans and to establish a safe starting dose for Phase 1 dose-escalation studies.
The data for RC220 will be used in all regulatory submissions requesting approval for its use in clinical trials, including US FDA Investigational New Drug (IND) applications.
Attentive Science was chosen as the most suitable contractor for the toxicology and safety pharmacology studies. An important component of the work is quantification of the bisantrene present in various biological samples.
Agilex Biolabs, a partner of Attentive Science and Australia’s largest provider of GLP compliant bioanalytical services, was selected to complete this important aspect.
Race has previously engaged Agilex Biolabs to develop validated GLP assays that meet global regulatory standards to quantify bisantrene levels in human/patient samples from Race clinical trials.