C&R Research Signs Clinical Outsourcing Contract for DimeBio's Anticancer Drug 'DM5167'

[Asia Economy Reporter Chunhee Lee] Clinical Research Organization (CRO) C&R Research announced on the 17th that it has signed a contract with Dime Bio for the Phase 1 and 2 clinical trials of the rare cancer and solid tumor treatment drug 'DM5167.'

Accordingly, C&R Research will undertake overall tasks including protocol development for DM5167, preparation for Investigational New Drug (IND) application, and clinical trial outsourcing. C&R Research plans to utilize its oncology-specific IT solution ‘OncoTrial Board’ and the metadata-based clinical process automation platform ‘imtrial’ to conduct everything from clinical trial design to submission in accordance with the standards of the Clinical Data Interchange Standards Consortium (CDISC).

A representative from C&R Research stated, “We plan to effectively conduct the domestic Phase 1 and 2 clinical trials of DM5167 by applying the clinical expertise we have accumulated through over 150 oncology clinical trials conducted in Korea. In particular, this trial will more effectively support CDISC-based clinical trial data standardization by utilizing our imtrial platform.”

DM5167 is an anticancer drug that regulates synthetic lethality and is a next-generation synthetic lethality drug with superior efficacy and improved safety compared to first-generation treatments. The two companies plan to begin IND approval from the Ministry of Food and Drug Safety and Phase 1 and 2 clinical trials of DM5167 early next year to assess tolerability, pharmacokinetic properties, and efficacy.