CEL-SCI Corporation announced on October 1, 2024, its renewed collaboration with Ergomed Clinical Research to serve as the Contract Research Organization (CRO) for its upcoming U.S. Food and Drug Administration (FDA) confirmatory Registration Study of Multikine. Ergomed will provide global comprehensive clinical operations support for the trial.
This partnership builds on their previous successful collaboration for the Phase 3 trial of Multikine, which was the largest study ever conducted in head and neck cancer. The confirmatory study is set to enroll 212 newly diagnosed patients with locally advanced primary head and neck cancer.
The study will focus on patients with no lymph node involvement and low PD-L1 tumor expression, a population where Multikine previously demonstrated a 73% 5-year survival rate versus 45% in control patients. The study is planned to commence in Q1 2025 in multiple countries.
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