TME Pharma announced today that the U.S. Food and Drug Administration (FDA) has approved its application to initiate a new clinical trial to evaluate its lead compound, 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 drug pembrolizumab (Merck's Keytruda®) and two different chemotherapy regimens in the second-line treatment of pancreatic cancer.

The study is expected to enroll around 70 patients at clinical sites in the U.S., as well as in France and Spain, where the study has already been approved.

' The approval by the Food and Drug Administration (FDA) of our IND application is a structuring step for TME Pharma, as it represents the first review and approval of NOX-A12 - and more globally the first review of our unique class of compounds - by the FDA', comments Aram Mangasarian, CEO of TME Pharma.

Copyright (c) 2023 CercleFinance.com. All rights reserved.