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news.CEL-SCI has started an open-label, randomized, controlled, multi-center Phase III clinical trial of head and neck cancer drug Multikine at the National Institute of Oncology in Budapest, Hungary.
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The company expects to recruit around 880 patients in over 40 hospitals in 9 countries.
The aim of this study is to establish Multikine as a first-line standard of care therapy in treating newly diagnosed head and neck cancer patients.
The study, named as immunotherapy Multikine anti tumor treatments (IT-MATTERS), is already ongoing at several clinical sites in the US, Canada, 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 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.