Amplia Therapeutics Limited (ASX:ATX) has received approval from the Korean Ministry of Food and Drug Safety (MFDS) to conduct the Phase 2a ACCENT clinical trial to test narmafotinib (AMP945) in combination with gemcitabine and Abraxane®, in advanced pancreatic cancer patients in Korea.
The approval from the Korean MFDS comes after many months of hard work from the Amplia team, who have worked closely with the Korean regulators, to achieve this important approval. The Korean health system and their clinical trial capability is world class, and recruitment into pancreatic cancer trials has been historically strong. We look forward to opening our planned sites in Korea and working with the excellent clinical groups, to further test the impact of our drug narmafotinib in the treatment of advanced pancreatic cancer.
Amplia Therapeutics Limited (ASX:ATX) has received approval from the Korean Ministry of Food and Drug Safety (MFDS) to conduct the Phase 2a ACCENT clinical trial to test narmafotinib (AMP945) in combination with gemcitabine and Abraxane®, in advanced pancreatic cancer patients in Korea. The approval paves the way for the commencement of patient enrolment at the preselected clinical trial sites in Korea. Amplia's CEO, Dr Chris Burns, expressed enthusiasm for the approval and highlighted the world-class clinical trial capability of the Korean health system. The company aims to further test the impact of their drug narmafotinib in the treatment of advanced pancreatic cancer and will provide updates as recruitment proceeds.