Race Oncology gets Korean IND approval for clinical trial in solid tumour patients

• RAC welcomes Investigational New Drug approval for cancer treatment in Korea
• Company plans to start patient recruitment shortly at four sites for the Phase 1 clinical trial
• Korean MFDS IND approval rigour is similar to that provided by the FDA or EMA

Special Report: Race Oncology has received Republic of Korea Ministry of Food and Drug Safety (MFDS) approval for its Investigational New Drug application for a phase 1 clinical trial of RC220 in solid tumour patients.

RC220 addresses the high unmet needs of patients across multiple oncology indications, with a clinical focus on anthracycline combinations, where RAC hopes to deliver cardio-protection and enhanced anti-cancer activity in solid tumours.

This Korean regulatory approval follows regulatory clearance in Australia and Hong Kong, with rigorous requirements comparable to the regulatory frameworks of the United States Food & Drug Administration (FDA) for IND applications, and the European Medicines Agency (EMA).

Race Oncology (ASX:RAC) said the Korean approval was granted after an extensive review of the chemistry, manufacturing and controls, non-clinical and clinical data package.

It enables the evaluation of the safety, tolerability and pharmacokinetics of RC220 in combination with doxorubicin in solid tumour patients, subject to minor updates of the trial protocol.

Watch: CEO Daniel Tillett 

Patient recruitment to commence at four sites

The approval also enables activation of the three pre-selected clinical trial sites in Korea – Samsung Medical Centre, Asan Medical Centre and EWHA Woman’s University Medical Centre – sites which also have received local ethics approval and can begin patient recruitment.

The fourth Korean site, Severance Hospital, is expected to be activated following IRB approval, anticipated in the next month.

“This approval allows patient enrolment in Korea and confirms the strength of the RC220 data package,” RAC CEO and managing director Dr Daniel Tillett said.

“We look forward to collaborating with our clinical partners in Korea to evaluate the potential of RC220 in combination with doxorubicin as a treatment option for adult patients with solid tumours.

“The Korean healthcare and regulatory systems are internationally recognised for their high standards.

“Patient recruitment into oncology trials in Korea has historically been robust.”

This article was developed in collaboration with Race Oncology, a Stockhead advertiser at the time of publishing.

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