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Pharma & Biotech

Race Oncology receives ethics approval to launch RC220 Phase 1 trial in Hong Kong

Two leading Hong Kong hospitals have greenlit participation in a study combining Race Oncology Ltd (ASX:RAC, OTC:RAONF)’s RC220 with doxorubicin. Race has secured Human Research Ethics Committee (HREC) approvals for its RC220 Phase 1 clinical trial at the Prince of Wales and Queen Mary Hospitals in Hong Kong. These approvals follow earlier Australian site activations and point to the momentum the company’s cardio-oncology program is building.

The trial, known as RAC-010, will assess the safety, tolerability and pharmacokinetics of RC220 — a reformulated bisantrene molecule — both alone and in combination with the chemotherapeutic agent doxorubicin.

The Queen Mary Hospital has already received formal approval from Hong Kong’s Department of Health, with the Prince of Wales Hospital expected to follow shortly. Site activations are anticipated in late July to mid-August.

“This trial is a declaration that cardio-oncology cannot be overlooked. RC220 may be the agent that protects the heart against doxorubicin damage and adds efficacy. We are very excited,” Dr Roland Ching-Yu Leung, principal investigator at Queen Mary Hospital, Hong Kong, said.

Dr Herbert Loong, Principal Investigator at Prince of Wales Hospital, Hong Kong, commented: “Cancer patients being treated with cardiotoxic agents need the potential cardiac protection and added efficacy that RC220 may bring. We are extremely excited to be recruiting patients to this important trial.”

Hong Kong trial sites broaden global clinical footprint

The decision to expand the RAC-010 trial to Hong Kong is based on three strategic considerations:

  1. Clinical investigator interest: Eminent physicians Dr Herbert Loong and Dr Roland Ching-Yu Leung will lead the study at their respective hospitals, recognising RC220’s potential to counter doxorubicin-related cardiotoxicity.
  2. Faster recruitment: Adding trial sites accelerates the collection of human data on the safety and potential dual efficacy of RC220.
  3. Geographic relevance: Including East Asian sites provides region-specific clinical safety and efficacy data in a key pharmaceutical market with high standards for research and regulation.

“We are delighted to have received human ethics approval for our RC220 Phase 1 trial in Hong Kong with the support of two internationally recognised clinical investigators. I wish to thank both Dr Loong and Dr Leung for their support and enthusiasm in progressing RC220 and I look forward to our respective teams working together in the coming months,” Race vice president of medical Dr Simon Fisher said.

Site and patient readiness progressing

The trial is designed for patients with solid tumours. Following site activation, clinicians at participating hospitals will assess patients for eligibility. Potential candidates under the care of the trial doctors or referred by their oncologists may enter the study after providing informed consent. Additional details, including site statuses, are available via clinicaltrials.gov.

These Hong Kong approvals follow previous HREC endorsements for sites in Australia, including Southside Cancer Centre (Miranda) and Gosford and Wyong Hospitals. Race expects to bring online up to four additional sites in South Korea, further broadening the RAC-010 trial's global reach.

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