Clinical Trial Authorization issued
DRIIM trial results
DRIIM trial completed its initially planned 4 dose escalations (16 mg, 32 mg, 48 mg and 64 mg DT01) without safety and tolerance issues. Dose-dependent tumor responses were observed.
French Competent Authority (AFSSAPS) issued its Clinical Trial Authorization (CTA) for DNA Therapeutics’ First-in-Human trial. There was no any question on the safety, quality of the investigational medicinal product – DT01, and trial protocol.
Application for Clinical Trial Authorization
DNA Therapeutics has submitted its application for Clinical Trial Authorization (CTA) to French Competent Authority (AFSSAPS), and to local Ethic Committee