SGM-101 has the potential to be the first tumor-targeted fluorescent probe to be marketed for fluorescence-guided surgery (FGS).
Montpellier, France, 16 July 2019 – SurgiMab today announces that the first surgical procedure was carried out in a pivotal Phase 3 clinical trial of the Company’s lead product, SGM-101, in a patient with colorectal cancer (CRC).
The randomized Phase 3 trial, designed following discussions with the FDA and other regulators, aims to enroll 300 CRC patients in ten clinical centers in Europe and US, and will assess the clinical benefit of using FGS with SGM-101 as the intraoperative imaging agent to identify cancer lesions during the surgical procedure. Patients will be injected with 10mg of SGM-101 four days prior to the scheduled CRC surgical procedure. Preliminary clinical data of the Phase 3 trial is expected in 2020.