CEL-SCI selects Ergomed as CRO for Multikine registration trial

CEL-SCI announced its renewed collaboration with Ergomed Clinical Research for its upcoming FDA confirmatory Registration Study of Multikine in head and neck cancer. Ergomed will provide global comprehensive clinical operations support to ensure the timely and efficient execution of the trial. This partnership builds on their previous collaboration for the Phase 3 trial of Multikine, which was the largest study ever conducted in head and neck cancer. CEL-SCI achieved other major milestones including receiving pediatric waivers from the UK’s Medicines & Healthcare Products Regulatory Agency and the European Medicines Agency. Multikine has already demonstrated promising results in its prior studies, showing a significant improvement in survival rates. In the target population for the confirmatory study, patients treated with Multikine had a 5-year survival of 73% vs 45% survival in the control patients, with a hazard ratio of 0.35. The confirmatory study is designed to provide the final data required for regulatory approval.