#Australia #Sydney #Racura Oncology #RC220 #CPACS Clinical Trial

Racura Oncology Receives Positive Review for CPACS Trial

Racura Oncology, an Australian biopharmaceutical company currently in Phase 3 clinical trials, has recently announced a significant milestone in its ongoing Cardioprotection and Anticancer Synergy (CPACS) clinical trial. On May 15, 2026, the independent Safety Review Committee (SRC) issued a positive recommendation to continue the trial, having conducted a thorough review of safety data from Cohort 1.

Recommendation from the SRC

The SRC evaluated the safety profile of Racura’s novel therapeutic, RC220, administered both as a standalone treatment (40 mg/m²) and in combination with doxorubicin (60 mg/m²) in patients with advanced metastatic solid tumors. According to Racura's CEO, Daniel Tillett, the SRC found no safety concerns within this cohort. This recommendation paves the way for Racura to continue advancing RC220 into the next cohorts of the study.

Daniel Tillett emphasized the importance of this feedback, stating, "The SRC's unanimous recommendation, alongside the lack of safety concerns, is a crucial milestone for our clinical program. We express our gratitude to the patients and their families for their invaluable participation in the CPACS trial."

Next Steps in the CPACS Trial

In light of the SRC's positive review, Racura Oncology plans to initiate the screening of new eligible patients for Cohort 2, where a higher dose (80 mg/m² of RC220) will be tested. The updated trial protocol includes an initial safety monotherapy cycle with doxorubicin before the administration of RC220, allowing researchers to assess the cardioprotective potential of the combination therapy through a blood-based molecular test. The company has acted quickly by notifying clinical trial sites to begin enrolling eligible patients in this new cohort.

About the CPACS Clinical Trial

The CPACS trial aims to explore how RC220 might protect against cardiotoxicity associated with anthracycline chemotherapy while enhancing its anticancer effects. This Phase 1 trial involves ascending doses of RC220 to determine the maximum tolerated combined dose with doxorubicin across a total of 33 patients using a Bayesian design. Moreover, various clinical biomarkers related to the cardioprotective mechanisms of RC220 are examined throughout the study.

An interim analysis will ascertain the optimal dosage of RC220 when combined with doxorubicin, extending the trial to an additional 20 patients to further evaluate safety, tolerability, and initial signals of efficacy.

About RC220

RC220 is a proprietary formulation derived from the agent (E,E)-bisantrene, chosen for its potential to overcome solubility barriers that hamper safe intravenous infusion. (E,E)-bisantrene is recognized as a validated small molecule anticancer agent that primarily impacts cancer growth regulation through its binding to G4-DNA and RNA.

Racura Oncology's Vision

Racura Oncology (ASX RAC) aims to silence cancer by progressing innovative treatments that address significant unmet medical needs in oncology. In addition to the CPACS trial, Racura is advancing its primary asset, RC220, through multiple clinical programs, including trials for acute myeloid leukemia and non-small cell lung cancer. Their intent is to deliver both cardioprotection and enhanced anticancer efficacy for patients undergoing treatment for solid tumors.

For more information, please visit Racura Oncology’s website.

Looking Ahead

The SRC's recommendation marks an optimistic turn in the CPACS trial and could lead to transformative changes in the treatment of solid tumors. Racura Oncology remains dedicated to pushing boundaries in cancer therapeutics and looks forward to sharing further developments as more data emerges from ongoing trials.