Race Oncology (ASX:RAC) has announced that a Certificate of Analysis (CoA) has been issued for the first current Good Manufacturing Practice (cGMP) batch of its proprietary bisantrene formulation, RC220.
The CoA confirms that the drug product meets the quality specifications required for human use.
Race contracted Ardena to manufacture the cGMP RC220 drug product to ensure that it meets the standards required by global regulatory authorities for human clinical use, including the European Medicines Agency (EMA), the US FDA and the Australian TGA.
Race said its bisantrene formulation is designed to enable its safe administration to patients via peripheral vein (arm or leg) intravenous infusions. It said cGMP batch of 2,600 vials of RC220 was manufactured in this campaign.
“The issued CoA confirms that RC220 meets the manufacturing quality specifications required for IV drug products to be used in humans,” said the company.
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.”
