Safety Review Committee (SRC) gives Racura Oncology a recommendation to continue the Cardioprotection and Anticancer Synergy (CPACS) study in advanced solid tumor patients

Racura Oncology, an Australian Phase 3 stage clinical biopharmaceutical company, today announced 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.

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.