On October 5, 2015 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") and its Clinical Research Organization (CRO) Ergomed plc (AIM: ERGO) reported that they have expanded their co-development agreement with increased activities to be undertaken by Ergomed (Press release, Cel-Sci, OCT 5, 2015, View Source [SID:1234507641]). Pursuant to the expanded co-development agreement, Ergomed’s contribution to the Phase 3 study will increase from $10,000,000 to $12,000,000. The companies are undertaking the Phase 3 trial of CEL-SCI’s investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer.
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Under the extended agreement, Ergomed will contribute up to $12,000,000 towards the cost of performing clinical services for the Phase 3 study in exchange for a single digit percentage of milestone and royalty payments, up to a specified maximum amount. Well over 500 patients have been enrolled in the world’s largest Phase 3 trial for head and neck cancer.
Ergomed CEO Miroslav Reljanovic stated, "At this point in the clinical trial we have decided to increase our investment in the development of Multikine, as we believe that it holds the potential to treat head and neck cancer in a new way. Our potential returns from this agreement will increase in line with our investment."
CEL-SCI CEO Geert Kersten added, "Working with a skilled CRO, our Phase 3 trial is making significant progress towards completing study enrollment goals. We are pleased to enter into this expanded co-development agreement with Ergomed. It further aligns Ergomed’s goals with CEL-SCI’s as Ergomed will be rewarded for its $12,000,000 co-development investment from the commercialization of the drug."
About the Multikine Phase 3 Study
The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.
About Multikine
Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.
Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at the University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF, which was added to the study in July 2015.