Race Oncology Gains Ethics Approval for RC220 Phase 1 Trial

3 min read | April 01, 2025 04:40 PM AEDT | By Team Kalkine Media

Highlights:

  • Race Oncology has secured human ethics approval for its Phase 1 trial of RC220 in combination with doxorubicin.

  • The trial will commence at Gosford and Wyong Hospitals in Australia, with patient enrollment expected in April.

  • Additional ethics approvals for sites in Australia, Hong Kong, and South Korea are anticipated in the coming months.

Race Oncology, a company in the pharmaceutical sector, has secured ethics approval for a Phase 1 clinical trial evaluating RC220 in combination with doxorubicin. This marks a significant milestone for the company as it progresses the development of its reformulated anti-cancer drug, bisantrene (RC220). The approval was granted by the Human Research Ethics Committee (HREC), allowing the trial to commence at Gosford and Wyong Hospitals within the Central Coast Local Health District in Australia.

Initiation of Phase 1 Trial at Key Sites
Following this approval, final site activations are underway, with patient enrollment expected to begin within April. The clinical study, designated as RAC-010, will focus on assessing the tolerability, safety, and pharmacokinetics of RC220, both as a standalone treatment and in combination with doxorubicin. This initiative represents an important step toward enhancing treatment options for patients with solid tumors.

Expanding the Reach of RC220 Trials
This approval follows a similar green light for Southside Cancer Centre in Miranda, reinforcing the clinical momentum of Race Oncology. Additional sites in Australia, Hong Kong, and South Korea are expected to receive approval in the near future. Most Australian sites are anticipated to be operational in the first half of the year, with international sites following later.

Commitment to Oncology Innovation
Race Oncology’s focus is on developing RC220 to address critical needs in oncology, particularly in anthracycline combinations. The company is working towards delivering a treatment approach that provides both cardio-protection and enhanced anticancer activity. This latest ethics approval highlights the continued efforts to bring RC220 to a broader patient base, contributing to advancements in cancer therapeutics.

Leadership’s Perspective on Progress
Race Oncology’s CEO and managing director, Dr. Daniel Tillett, expressed appreciation for the dedication of the team involved in reaching this milestone. The approval was made possible through collaborative efforts with Bellberry HREC and George Clinical teams. Race Oncology’s chief medical officer, Dr. Michelle Rashford, emphasized that this development further drives momentum for the study and the broader goal of delivering RC220 to patients.

Future Development Plans
With the activation of multiple trial sites, Race Oncology continues to expand its clinical footprint. As more approvals are secured in different regions, the company remains committed to advancing RC220 through rigorous clinical evaluation. This development also highlights Race Oncology’s contributions to the asx, healthcare Stocks sector, with the company trading under the ticker ASX:RAC and OTC:RAONF.

The ongoing efforts to establish RC220 as a viable treatment option reflect the company’s focus on addressing unmet medical needs. As trial sites become fully operational, further updates on patient enrollment and trial progression are expected.


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