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Israeli government approves CEL-SCI to start Multikine Phase III trial

The State of Israel Ministry of Health has approved CEL-SCI to commence patient recruitment in an open-label, randomized, controlled, multi-center Phase III clinical trial, to be conducted by CEL-SCI's partner, Teva Pharmaceutical for Multikine in Israel.

Multikine is CEL-SCI’s immunotherapy which was developed as a standard of care in treating head and neck cancer.

The Phase III trial is designed to determine if Multikine administered prior to current standard of care 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.

CEL-SCI said the Phase II clinical trials of Multikine demonstrated that the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment.