The company received an FTD from the US FDA for ITM-11 to treat gastroenteropancreatic neuroendocrine tumors currently being evaluated in the P-III (COMPETE) & (COMPOSE) study
The P-III (COMPETE) & (COMPOSE) trials evaluate the safety & efficacy of ITM-11 vs standard therapy in patients (n=309 & 202) with inoperable, progressive, grade 1 & 2 (COMPETE) & grade 2 & 3 (COMPOSE) SSTR+ neuroendocrine tumors of GEP-NETs. The 1EPs of the study includes PFS & the 2EPs includes OS
ITM-11 is a therapeutic radiopharmaceutical comprised of a medical radioisotope n.c.a. 177Lu & the targeting molecule edotreotide which is a synthetic form of the peptide hormone somatostatin targeting the neuroendocrine tumor-specific receptors
Ref: GlobeNewswire | Image: ITM
