CEL-SCI reports results from Multikine bias analysis

CEL-SCI reported results from a bias analysis conducted for its concluded Phase 3 study of Multikine in the treatment of head and neck cancer. Conducting a bias analysis is a standard process used to identify, assess, and address potential sources of bias that could influence the outcomes and interpretations of study results. CEL-SCI’s bias analysis concluded that the treatment group demographics and baseline characteristics were comparable for the Multikine treated and control arms of the Phase 3 study. There were no confounding baseline parameters in the Multikine-treated versus control population. No bias was present in the study and none was detected in favor of the investigational product, Multikine. As such, the study data are interpretable, statistically significant and have been shown to support the clinical effect of neoadjuvant Multikine immunotherapy in extending the life of these patients in the Phase 3 study. This is critically important information because CEL-SCI, with the FDA’s agreement, will be conducting a 212-patient confirmatory registration study for Multikine. The target population for the confirmatory study shows a five-year survival in advanced primary head and neck cancer of 73% in Multikine treated patients vs. 45% survival in the control.