The study is intended to establish 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 versus subjects treated with standard of care only.
Earlier, in a Phase II clinical trials, Multikine was safe and well-tolerated and eliminated tumors in 12% of subjects, which are the patient population now being selected for the Phase III Study.
The trial also demonstrated a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery.
CEL-SCI CEO Geert Kersten said they are very excited to begin this pivotal study in the first center outside of the US and expect foreign centers to attract a significant number of patients, which will compress the time period necessary to complete the study.