Posted: 5 December 2023
Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to announce that the Korean Ministry of Food and Drug Safety (MFDS) have approved the clinical trial to test narmafotinib (AMP945) in combination with gemcitabine and Abraxane®, in advanced pancreatic cancer patients in Korea.
This approval means that the five preselected clinical trial sites in Korea can be opened shortly to commence enrolment of patients. Six sites in Australia were opened in November and experience at these sites with the initial 1B Phase of the ACCENT trial will help optimise the recruitment and management of patients in this important Phase 2 stage of the trial both in Australia and Korea.
Amplia’s CEO and Managing Director Dr Chris Burns commented: “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.”
