CEL-SCI Corporation (NYSE American: CVM) has announced a renewed collaboration with Ergomed Clinical Research to conduct a confirmatory FDA Registration Study of Multikine (Leukocyte Interleukin, Injection) for head and neck cancer. This partnership aims to solidify Multikine's potential as a first-line treatment for patients with locally advanced primary head and neck cancer.
Trial Design and Patient Population
The upcoming study is designed to enroll 212 newly diagnosed patients who have locally advanced primary head and neck cancer, specifically targeting those without lymph node involvement and with low PD-L1 tumor expression. This patient selection is based on previous data indicating a more significant benefit from Multikine in this subgroup. The trial is planned to commence in Q1 2025 and will be conducted across multiple sites globally.
Prior Study Results
Multikine has demonstrated promising results in earlier studies. Notably, in the target population for the confirmatory study, patients treated with Multikine showed a 5-year survival rate of 73% compared to 45% in the control group, resulting in a hazard ratio of 0.35. These results suggest a substantial reduction in the risk of death for patients treated with Multikine.
Collaboration with Ergomed
Ergomed will provide comprehensive clinical operations support to ensure the efficient execution of the trial. This collaboration builds on a previous successful partnership between CEL-SCI and Ergomed during the Phase 3 trial of Multikine, which was the largest study ever conducted in head and neck cancer. Geert Kersten, CEO of CEL-SCI, commented, "Ergomed is a trusted partner... Their enrolment was fast and the study was clean."
Regulatory Milestones
In addition to the upcoming confirmatory study, CEL-SCI has achieved other regulatory milestones, including receiving pediatric waivers from the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA). These waivers and positive feedback from the FDA are indicative of the progress in clearing regulatory hurdles for Multikine.
Implications for Head and Neck Cancer Treatment
If the confirmatory study replicates the prior positive results, Multikine could represent a significant advancement in the treatment of head and neck cancer. Dr. Sy Pretorius, CEO of Ergomed Group, stated, "Together, we aim to advance innovative therapies that can make a real impact on patients' lives."
