Race Oncology (ASX: RAC) has made further progress in the development of its proprietary bisantrene formulation drug, RC220 – whereby a Certificate of Analysis (CoA) for the first current Good Manufacturing Practice (cGMP) batch has been issued, which confirmed its suitability for human use.
RC220 is an innovative bisantrene formulation designed for safe administration to patients through peripheral vein intravenous (IV) infusions. This formulation builds upon successful research and development conducted by Race’s lab team at the University of Wollongong.
Ardena, a company contracted by Race, manufactured the cGMP RC220 drug product to meet the rigorous standards mandated by global regulatory authorities such as the European Medicines Agency (EMA), the US Food & Drug Administration (FDA), and the Australian Therapeutic Goods Administration (TGA).
The cGMP batch of RC220, comprising 2600 vials, meets the stringent quality specifications required for IV drug products used in human clinical studies. Compliance with cGMP standards ensures that RC220 is suitable for evaluation in Phase 1 & 2 clinical trials in regions including Asia-Pacific, Europe, and the USA.
“This is a major milestone to have reached and means we have manufactured RC220 to a standard suitable to start our Phase 1 clinical trial here in Australia,” Race Oncology Chief Marketing Officer Dr Michelle Rashford said.
This achievement marks a significant step forward in Race Oncology’s efforts to bring innovative treatment options to cancer patients.
RAC has been trading at $1.39.