The first Good Manufacturing Practice (cGMP) batch of RC220, the proprietary bisantrene formulation of Race Oncology Ltd (ASX:RAC, OTC:RAONF), is complete and it has received a Certificate of Analysis (CoA).
The CoA, issued by Ardena, confirms that this first cGMP batch of RC220 meets the stringent quality standards required for human intravenous (IV) drug products.
Rigorous quality specifications
The cGMP manufacturing campaign resulted in the production of 2,600 vials of RC220, each meeting the rigorous quality specifications required for IV drug products intended for human use.
According to the CoA, RC220 complies with all cGMP specifications necessary for its intended use in human clinical trials.
The company has lauded this as a “major milestone in the progress of RC220 for use in human clinical trials”.
Race engaged Ardena for the cGMP manufacturing of RC220 to ensure adherence to the exacting standards mandated by major global regulatory bodies, including the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Australian Therapeutic Goods Administration (TGA).
Race's innovative bisantrene formulation, RC220, is specifically designed to facilitate the safe administration of bisantrene to patients through peripheral vein IV infusions in clinical settings.
Successful research and development
This builds upon successful research and development efforts conducted by Race's laboratory team at the University of Wollongong.
The achievement positions Race favourably for the evaluation of RC220 in Phase 1 and 2 clinical studies across the Asia-Pacific region, Europe and the USA.
Race Oncology Ltd (ASX:RAC, OTC:RAONF) continues to make strides in advancing innovative pharmaceutical solutions, with the completion of cGMP manufacturing for RC220 marking a significant step forward in its clinical development journey.
CEO Dr Daniel Tillett said: “Reaching this point in the development of bisantrene is a major milestone and accomplishment.
“The original developers of bisantrene, Lederle Laboratories, tried for nearly a decade to make a formulation of bisantrene that could be delivered via a peripheral vein without success. It is a testament to the dedication and skill of the Race team that we were able to accomplish what Lederle could not.
“I, along with the entire team at Race, are looking forward to completing the GLP toxicology testing of RC220 in the coming months and beginning the clinical program that will give patients access to bisantrene in a format that is both easier and safer to use.”
CMO Dr Michelle Rashford said: “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.”