On September 26, 2023 CEL-SCI Corporation (NYSE American: CVM) reported that it has filed a request for Scientific Advice regarding Multikine* (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN) with the European Medicines Agency’s (EMA’s) Scientific Advice Working Group (Press release, Cel-Sci, SEP 26, 2023, View Source [SID1234635433]).

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Europe is a high priority market for CEL-SCI, as Europe has 150,000 new annual cases of head and neck cancer, more than twice the 68,000 cases diagnosed each year in the U.S.

"We look forward to discussing with the Scientific Advice Working Group the positive clinical data from our completed Phase 3 study of Multikine in head and neck cancer. The goal is to obtain the Working Group’s opinion regarding this information and reach an agreement with them on a plan which will allow us to file for marketing authorization in the EU as soon as possible" stated CEL-SCI’s CEO Geert Kersten. "This is part of our global regulatory approval strategy. We concurrently plan to pursue filings for marketing authorization in multiple countries. There is no question about the dire need for a new and effective treatment for newly diagnosed SCCHN patients, and we are hopeful that regulators will appreciate the robust data and results from our Phase 3 study that demonstrate Multikine’s efficacy and safety."