Amplia Therapeutics Announces Opening of US Sites for Amplicity Pancreatic Cancer Trial

Company Overview - Amplia Therapeutics Limited is an Australian pharmaceutical company focused on developing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis, particularly in fibrotic cancers such as pancreatic and ovarian cancer [5] - Narmafotinib (AMP945) is the company's leading drug, recognized as a best-in-class FAK inhibitor, which is over-expressed in pancreatic cancer and is gaining attention as a drug target for solid tumors [6] AMPLICITY Trial Details - The AMPLICITY trial is investigating the safety, tolerability, efficacy, and pharmacokinetics of narmafotinib in combination with modified FOLFIRINOX in newly diagnosed patients with advanced pancreatic cancer [8] - The trial is designed as a single-arm, open-label study, proceeding in two parts to identify the optimal daily dose of narmafotinib [9][10] - Currently, the trial has initiated two sites in the US (University of California, Irvine and The Cleveland Clinic) and has two sites open in Australia, with three additional US sites expected to open soon [2][3][6] Clinical Trial Progress - The AMPLICITY trial aims to expand the potential patient base significantly, enhancing the company's presence in the US from both clinical and investor perspectives [3] - The trial is being conducted under an open IND from the US FDA, and further information can be found on the trial's website [8][10] - Previous preclinical studies have shown that the addition of narmafotinib to FOLFIRINOX significantly improves survival in animal models of pancreatic cancer compared to FOLFIRINOX alone [11]