GARCHING & MUNICH, Germany--(BUSINESS WIRE)--ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the presentation of the study design for its phase III trial, COMPOSE (NCT04919226), at the ASCO Gastrointestinal Cancers Symposium (ASCO-GI), held from January 20 – 22, 2022. COMPOSE will evaluate the company’s lead radiopharmaceutical candidate, ITM-11 (n.c.a. 177Lu-edotreotide), compared to best standard of care in patients with well?differentiated high grade 2 and grade 3 somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (G2+G3 SSTR+ GEP-NETs). ITM-11 consists of the high-quality radioisotope, no-carrier-added lutetium-177 (n.c.a. 177Lu) chelated to the somatostatin analogue edotreotide. The aim of the study, in which patients are currently being randomized, is to evaluate the efficacy and safety of the Targeted Radionuclide Therapy in this high-need indication. COMPOSE is ITM’s second phase III trial with ITM-11 following and building upon COMPETE (NCT03049189), in patients with grade 1 and grade 2 GEP-NETs. Sponsor of the COMPOSE study is ITM’s subsidiary ITM Solucin GmbH.
Eight medicines have taken a big leap towards being approved in Europe having won the support of the European Medicines Agency's Committee for Medicinal Products for Human Use.
Eleven new medicines have taken a giant leap closer to European Union approval after having won the backing of the Committee for Medicinal Products for Human Use.