CEL-SCI FILES PHASE III CLINICAL TRIAL APPLICATION WITH FDA

CEL-SCI has submitted a Phase III clinical trial protocol to the FDA for the use of its investigational immunotherapy drug Multikine in the treatment of advanced primary squamous cell carcinoma of the oral cavity.

The protocol was designed in consultation with a group of recognized experts in the field of head and neck cancer therapy to develop the conclusive evidence of the safety and efficacy of Multikine in the treatment of advanced primary squamous cell carcinoma of the oral cavity that would be required to license the product.

The company plans to meet with the FDA to discuss the proposed Phase III clinical trial over the next several months and obtain the agency's approval to initiate the study.