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news.CEL-SCI's Taiwanese partner Orient Europharma is set to start a controlled, multi-center, open-label and randomized Phase III clinical trial of head and neck cancer drug Multikine at Shin Kong Wu Ho-Su Memorial Hospital in Taiwan.
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Orient Europharma intends to team up with 6 other Taiwanese clinical centers for conducting the study, named as immunotherapy Multikine anti tumor treatments (IT-MATTERS), which is already ongoing at several clinical sites in the US, Canada, Hungary, Poland and India.
The company expects to recruit around 800 head and neck cancer patients in over 40 hospitals in 9 countries.
CEL-SCI‘s partner Teva Pharmaceuticals will conduct parts of the Phase III study in Israel.
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.
CEL-SCI CEO Geert Kersten said the goal of this study is to establish Multikine as a first-line standard of care therapy in treating newly diagnosed head and neck cancer patients.