(CercleFinance.com) – TME Pharma announces today that the US Food and Drug Administration (FDA) has approved its request to launch a new clinical trial aimed at evaluating its main asset, NOX-A12, in a phase 2 study in pancreatic cancer (OPTIMUS) in the United States.
The Optimus study is designed to evaluate the safety and efficacy of NOX-A12 in combination with the anti-PD-1 pembrolizumab (Keytruda® from Merck) and two different chemotherapy regimens in the second-line treatment of cancer of the pancreas.
The study is expected to enroll approximately 70 patients at clinical sites in the United States, as well as France and Spain, where the study has already been approved.
‘The Food and Drug Administration (FDA) approval of our IND application is a defining milestone for TME Pharma, as it represents the first review and approval of NOX-A12 – and more broadly the first review of our unique class of compounds – by the FDA,” comments Aram Mangasarian, CEO of TME Pharma.