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NEWS
CEL-SCI Highlights Biological Rationale for the Use of Multikine in the Confirmatory Registration Head and Neck Cancer Study
Thursday, 12th December at 9:15 am
• 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)
Thursday, 12th December at 9:15 am
• 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)
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