The company expects to recruit around 880 patients in 48 hospitals in 9 countries across three continents.
The study, named as immunotherapy Multikine anti tumor treatments (IT-MATTERS), is already ongoing at several clinical sites in the US, Poland and India.
CEL-SCI’s partners Teva Pharmaceuticals and Orient Europharma will conduct parts of the Phase III study in Israel and Taiwan respectively.
The Phase III trial intends to determine whether Multikine administered before current standard of care used for treatment naive subjects with head and neck cancer will result in an increased overall rate of survival versus subjects treated with standard of care only.
The Phase II trial results showed that Multikine is safe and well-tolerated and eliminated tumors in 12% of subjects, which are the patient population now being selected for the Phase III Study.