RE: Novartis23 May 2024 08:15
'SOFIE granted IND for 18F-FAPI in Phase 2 study
Dulles, VA – November 29, 2022 – SOFIE Biosciences (SOFIE), an established US manufacturer and developer of radiopharmaceuticals, has received Investigational New Drug (IND) clearance to proceed with clinical study of [18F]FAPI-74, its lead fluorine-18 labelled Fibroblast Activation Protein Inhibitor (FAPI) product. The study accepted as part of the FDA IND review is for a Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in patients with Gastrointestinal Cancers. The cancer types included as part of this study are: gastric cancer, cholangiocarcinoma, hepatocellular carcinoma, pancreatic cancer and colorectal cancer.'