regulatory
confidence high
sentiment positive
materiality 0.70
CEL-SCI to pursue Health Canada's conditional approval pathway for Multikine in head & neck cancer
CEL SCI CORP
- Health Canada advised CEL-SCI to request approval under Notice of Compliance with Conditions (NOC/c) policy for Multikine.
- Plans to file drug submission for earlier access in Canada while preparing U.S. BLA and pursuing other country approvals.
- Phase 3 IT-MATTERS study in head & neck cancer showed median OS improvement of 46.5 months for lower-risk patients.
- Five-year survival: 62.7% for Multikine vs 48.6% control; tumor shrinkage >30% in ~1 of 6 patients in 3 weeks.
- 5 patients had complete tumor disappearance in 3 weeks prior to surgery.