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news.CEL-SCI's partner Teva Pharmaceuticals is set to start a controlled, multi-center, open-label and randomized Phase III clinical trial of head and neck cancer drug Multikine at Tel Aviv Sourasky Medical Center in Israel.
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Teva intends to team up with another two Israeli clinical centers for conducting the study (immunotherapy Multikine anti tumor treatments (IT-MATTERS)), which is already ongoing at several clinical sites in the US, Canada, Hungary, Poland, Taiwan and India.
The company expects to recruit around 880 head and neck cancer patients in over 40 hospitals in 9 countries.
CEL-SCI‘s partner Orient Europharma will conduct parts of the Phase III study in Taiwan.
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 Teva has experience and expertise in conducting clinical trials, and they are excited about the relationship they have established with the company as they conduct this Phase III trial.
"The trial is designed to demonstrate that Multikine represents a new paradigm in the treatment of head and neck cancer," Kersten said.