CEL-SCI notifies availability of Multikine Phase 3 confirmatory study launch release

• CEL-SCI published a release launching a global Phase 3 confirmatory, registration-enabling study of Multikine for newly diagnosed, resectable head and neck cancer.
• Trial targets 212 patients with low or zero PD-L1 expression and no clinical lymph node involvement; enrollment planned across the U.S., Europe, Asia, later South America.
• Study design targets about 97% power to confirm a 0.34 hazard ratio on overall survival; prior target subgroup showed 73% 5-year survival vs 45%.
• Pre-surgical tumor response endpoints may support an FDA accelerated or conditional approval filing while overall survival follow-up continues.

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