Approval from Korean regulator to initiate Phase 2 accent pancreatic cancer trial in Korea   

Amplia has today announced that the Korean Ministry of Food and Drug Safety (MFDS) has approved a clinical trial to test narmafotinib (AMP945) in combination with gemcitabine and Abraxane®, in advanced pancreatic cancer patients in Korea. 

This approval means that five preselected clinical trial sites in Korea can be opened shortly to commence enrolment of patients for the Phase 2a stage of the ACCENT clinical trial.  These sites will operate in addition to six existing sites across Australia. 

Amplia’s CEO and MD, 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.” 

Click here to read today’s ASX release.