On May 15, 2026 Racura Oncology, an Australian Phase 3 stage clinical biopharmaceutical company, reported that the independent Safety Review Committee (SRC) has completed its review of safety data from Cohort 1 of the ongoing CPACS clinical trial, evaluating the safety and pharmacokinetics of RC220 alone and in combination with doxorubicin in advanced metastatic solid tumor patients.

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Following its review, the SRC recommended that the study continue, noting no safety concerns in patients treated with 40mg/m2 of RC220 as monotherapy, or 40mg/m2 of RC220 in combination with 60mg/m2 of doxorubicin, in the first patient cohort of this groundbreaking trial.

"The SRC’s unanimous recommendation to proceed with the trial, along with the absence of any safety concerns, represents an important milestone for this clinical program," said Daniel Tillett, CEO of Racura Oncology. "These findings support the continued advancement of RC220 into the next cohorts of this study. We wish to thank the patients and their families for their courage and generosity shown by participating in the CPACS trial."

Based on this positive SRC recommendation, Racura plans to proceed to screening of new eligible patients for enrolment in Cohort 2 (80mg/m2 RC220 dose level) using an updated trial protocol, which includes an initial lead-in safety monotherapy cycle of doxorubicin prior to the administration of RC220. This protocol update enables an assessment of the anthracycline-cardioprotective potential of RC220 using a blood-based molecular test.

The Company has received the SRC’s formal written recommendation and has promptly notified the clinical trial sites to initiate enrolment in Cohort 2, as patients present and meet the eligibility criteria.

About Cardioprotection and Anticancer Synergy (CPACS) Trial

The CPACS Phase 1 solid tumor clinical trial is exploring the preclinical discovery that RC220 can provide protection from anthracycline cardiotoxicity while improving the anticancer activity of anthracyclines. Stage 1 of the trial is using ascending doses of RC220 to determine the safety, tolerability, pharmacokinetics, and maximum tolerated combined dose (MTCD) of RC220 in combination with doxorubicin in up to 33 patients using a Bayesian design. The effects on a range of clinical biomarkers, including a blood-based measure of the cardioprotective mechanism of action of RC220, are also being explored in the study.

After interim analysis of the data, the optimal dosage of RC220 in combination with doxorubicin will be assessed in an additional 20 patients in Stage 2 for further safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals. This open-label trial is being conducted across multiple sites in Australia, Hong Kong, and South Korea.

About RC220 & (E,E)-bisantrene

RC220 is a proprietary formulation of (E,E)-bisantrene designed to overcome drug solubility issues that prevent safe peripheral intravenous infusion. (E,E)-bisantrene is a clinical validated small molecule anticancer agent that primarily functions via G4-DNA and RNA binding, leading to potent silencing of the important cancer growth regulator MYC.

(Press release, Racura Oncology, MAY 15, 2026, View Source [SID1234665796])