Phase 3 study of Multikine for the treatment of head and neck cancer

CEL-SCI Corporation announced it has commenced a Phase 3 trial for Multikine for the treatment of newly diagnosed head and neck cancer patients. This trial is an open-label, randomized, controlled, multi-center study designed to determine if Multikine administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Radiochemotherapy) used for treatment naive subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival (the primary endpoint) versus the subjects treated with standard of care only. The Company expects to enroll approximately 880 patients at about 48 clinical centers in 9 countries (including the US) in the IT-MATTERS trial.

Multikine is an immunotherapeutic agent being developed as a first-line treatment for cancer. It is a defined mix of cytokines that includes interleukins, interferons, chemokines, and colony stimulating factors; all are molecules which stimulate the body’s healthy, active and passive immune response.

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