Race Oncology Limited recently announce the appointment of George Clinical to support the oncology clinical development of RC220 bisantrene. George Clinical was selected after an extensive and rigorous selection process conducted by the Race Oncology clinical team. In addition to clinical trial expertise, George Clinical, brings access to a supplementary network of key opinion leading clinical oncologists with extensive expertise in the treatment of solid tumors with anthracyclines. These clinical experts will assist Race in the refinement and efficient execution of the proposed Phase I study of peripherally administered intravenous RC220 bisantrene in combination with a standard-of-care regimen of doxorubicin in patients with advanced solid tumors.

The Phase I trial will be conducted under an open label in two stages across multiple sites in Australia, Hong Kong and South Korea. The first Phase Ia stage will study ascending doses of RC220 bisantrene to determine safety, tolerability, pharmacokinetics, m6 A RNA effects, and the maximum tolerated dose alone and in combination with doxorubicin. In the second Phase Ib stage, the optimal dosage of RC220 bisantrene in combination with doxorubicin will be assessed for additional safety, tolerability, and preliminary cardio-protective and anticancer efficacy signals. The Phase I trial will use a Bayesian design allowing for greater trial flexibility and speed. The final trial protocol and commencement of the trial is subject to human ethics and institutional approvals.

Race Chief Executive Officer Dr. Daniel Tillett commented

“This agreement with George Clinical is a significant milestone for Race to bring RC220 bisantrene to the clinic to potentially protect patients from the heart damage caused by anthracyclines while improving the treatment of their cancer. I welcome the opportunity for Race to work with George Clinical and wish to thank the Race clinical team for their hard work and dedication in reaching this agreement.”

Race Chief Medical Officer Dr. Michelle Rashford added

“This is a key foundational study to establish important safety and drug absorption kinetics for RC220 and provide appropriate doses for effective combination with doxorubicin to advance the development of RC220 for clinical cardiac benefit to patients treated with anthracyclines while providing improved outcomes. We are delighted George Clinical can support this significant step for Race and through the selection process their responsiveness and clinical insight has impressed us. I and the rest of Race clinical team look forward to working with George Clinical on this and future trials.”