SurgiMab, a late-stage biotechnology company pioneering a new antibody-based fluorescence-guided approach with the aim to improve cancer surgery and clinical outcomes for patients, announces that the first US patient has been recruited into its on-going pivotal Phase 3 clinical trial evaluating its investigational imaging agent SGM-101 in patients undergoing colorectal cancer (CRC) surgery.
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 the US. The trial will assess the safety and clinical benefit of using fluorescence-guided surgery (FGS) with SGM-101 as an intraoperative imaging agent to better identify cancer lesions during the surgical procedure. Patients are injected with 10mg of SGM-101 four days prior to the scheduled CRC surgical procedure. Preliminary clinical data from the Phase 3 trial is expected in 2020.