The company expects to recruit around 85 patients in five clinical trial centers in the Poland.
The Phase III trial intends to establish 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.
CEL-SCI‘s partners Teva Pharmaceuticals and Orient Europharma will conduct parts of the Phase III study in Israel and Taiwan respectively.