Race Oncology Ltd (ASX:RAC) has been approved for its Phase One trial of its chemotherapeutic candidate RC220 to treat people with solid tumours.

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The approval – granted by the Bellberry Human Research Ethics Committee (HREC) – allows Race to push ahead with a trial to test the tolerability, safety, and pharmacokinetics of RC220 bisantrene on its own and together with doxorubicin.

Race is collaborating with Cancer Care Foundation on this trial. The approval means the Foundation’s main site, which is based at the Southside Cancer Care Centre in New South Wales, will soon be able to begin enrolling patients under the guidance of Principal Investigator Dr Mahmoud Alam.

This trial – which is open-label and multi-centre – will run across two phases, with 33 patients in the first phase receiving RC220 through intravenous infusion alone, followed by a combination treatment of IV RC220 and IV doxorubicin on a 21-day cycle.

In the Phase Two expansion stage, patients with solid tumours will be enrolled, receiving the optimal dosage of RC220 in combination with doxorubicin to check the safety of these two combined, as well as looking at several exploratory endpoints.

Bisantrene – Race’s focal asset – is a “small molecule chemotherapeutic” which has been showing therapeutic benefits for both adult and child patients, and data supporting its anticancer effects as well as indicating its lower cardiotoxicity in comparison to anthracyclines such as doxorubicin.

RC220 is being developed as a reformulated bisantrene (RC220).

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Race chief executive officer and managing director Dr Daniel Tillett said the approval was an important step.

“Receiving human ethics approval for the first RC220 trial is a significant milestone for Race, in line with our vision to improve cancer patient treatment by developing new cardioprotective therapies with anticancer benefits,” he said.

“I wish to thank the Bellberry HREC and the entire Race and George Clinical teams for all their efforts, which enabled us to reach this critical milestone.”

Race has been trading at $1.03 this morning.

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