Race Oncology (ASX:RAC) said South Korea's Ministry of Food and Drug Safety (MFDS) approved the investigational new drug application (IND) to evaluate the safety, tolerability, and pharmacokinetics of the company's cancer drug candidate RC220 in combination with doxorubicin in solid tumor patients, subject to minor updates of the trial protocol, according to a Wednesday Australian bourse filing.
The approval has been granted following a review of the chemistry, manufacturing, and controls, as well as nonclinical and clinical data packages for RC220, the filing added.
The company said the approval enables patient recruitment at four sites in South Korea, with local ethics approval received.
The company's shares rose 8% in recent Wednesday trade.