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CEL-SCI's head and neck cancer treatment trial gets FDA go-ahead

The U.S. Food and Drug Administration lifted the full clinical hold on the phase 3 head and neck cancer trial for CEL-SCI Corp.'s Multikine.

The study's primary endpoint is a 10% increase in overall survival in patients given the Multikine treatment regimen plus standard of care compared to those who receive only the current standard of care.

FDA designated Multikine an orphan drug for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck.

The phase 3 trial had been placed on partial clinical hold in September 2016 after the regulator identified deficiencies in the study, including a significant risk of illness or injury to human subjects, a misleading investigator brochure and a deficient plan to meet the trial's stated objectives.