On October 1, 2024 CEL-SCI Corporation (NYSE American: CVM) reported its renewed collaboration with Ergomed Clinical Research for its upcoming U.S. Food and Drug Administration (FDA) confirmatory Registration Study of Multikine (Leukocyte Interleukin, Injection) in head and neck cancer (Press release, Cel-Sci, OCT 1, 2024, View Source [SID1234646991]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ergomed will provide global comprehensive clinical operations support to ensure the timely and efficient execution of the trial, supporting CEL-SCI in bringing a new treatment option for patients with locally advanced primary head and neck cancer to the market.

This partnership marks a continuation of the successful cooperation between the two companies, building on their previous collaboration for the Phase 3 trial of Multikine, which was the largest study ever conducted in head and neck cancer.

In addition to the positive outcome from its recent meeting with the FDA regarding the path to approval for its first-line investigational cancer immunotherapy, CEL-SCI achieved other major milestones including receiving pediatric waivers from the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

This confirmatory study represents a crucial step toward potential marketing approval of Multikine. The study, set to enrol 212 newly diagnosed patients with locally advanced primary head and neck cancer, will focus on patients with no lymph node involvement and low PD-L1 tumour expression. Patients will be enrolled across multiple sites globally, underscoring the strength of Ergomed’s global clinical trial management capabilities.

Geert Kersten, CEO of CEL-CI commented, "Ergomed is a trusted partner. Our past experience taught us that they are highly competent and motivated. Their enrolment was fast and the study was clean. The plan is for the study to commence in Q1 2025 in multiple countries."

Dr. Sy Pretorius, CEO of Ergomed Group, added, "We are excited to once again partner with CEL-SCI on this significant trial for Multikine. Our prior collaboration has set a strong foundation for this new phase, and we are committed to leveraging our global expertise in oncology clinical research to support this critical confirmatory study. Together, we aim to advance innovative therapies that can make a real impact on patients’ lives."

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, bringing Multikine one step closer to becoming a breakthrough treatment option for head and neck cancer patients worldwide.