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news.The Biologics and Genetic Therapeutics Directorate of Health Canada has approved CEL-SCI to commence patient recruitment in an open-label, randomized, controlled, multi-center Phase III clinical trial of Multikine to treat head and neck cancer patients.
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The trial is intended to establish if Multikine administered prior to current standard of care (surgery plus radiotherapy or surgery plus concurrent chemo radiotherapy) in previously untreated subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (head and neck cancer) will result in an increased overall rate of survival, versus the subjects treated with standard of care only.
The trial will be organized in approximately 48 clinical centers in nine countries.
CEL-SCI‘s partner Teva Pharmaceutical Industries will be conducting the trial at three clinical centers in Israel and its partner Orient Europharma will be conducting the trial at seven clinical centers in Taiwan.
The Phase II clinical trials of Multikine showed that the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment.