• Multikine is the first cancer immunotherapy to show pre-surgical tumor regression in head and neck cancer in just 3 weeks - confirmed by pathology at surgery
• Factors supporting the go-ahead for the 212-person registration study in the target population include:
  • Multikine led to significant rates of tumor regression
  • Pre-surgical tumor regressions were confirmed at surgery and forecast survival benefit
  • Target population is likely to show significant survival prolongation in the confirmatory study
• Confirmatory study target population selection is based on:
  • Strong statistical significance in a large subgroup of 114 patients
  • Subgroup analysis was pre-defined in the statistical analysis plan (SAP)
  • Strong biological rationale for the results based on Multikine's mechanism of action (MOA)

CEL-SCI Corporation (NYSE:CVM) today highlights strong biological rationale for the use of Multikine in the confirmatory registration head and neck cancer study. This study of 212 newly diagnosed locally advanced, resectable head and neck cancer patients was given the go-ahead as a confirmatory registration study by FDA and will focus on those patients who showed a 73% survival with Multikine vs. a 45% for the control patients not treated with Multikine in the prior Phase 3 study.