Korean regulator approves Amplia Therapeutics' pancreatic cancer trial

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The Korean Ministry of Food and Drug Safety has approved Amplia Therapeutics' (ASX:ATX) clinical trial to test narmafotinib (AMP945) in combination with gemcitabine and abraxane in advanced pancreatic cancer patients.

The company said the 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.

Amplia CEO and managing director Dr Chris Burns said, “The approval from the Korean MFDS [Ministry of Food and Drug Safet] 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.”