On June 22, 2023 CEL-SCI Corporation (NYSE American: CVM) reported that it will present the new data from its pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN), at the American Head and Neck Cancer Society’s (AHNS) 11th Annual International Conference on Head and Neck Cancer on July 8-12, 2023 in Montreal, Canada (Press release, Cel-Sci, JUN 22, 2023, View Source [SID1234632859]).
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"This data to be presented at AHNS, in our view and also in the view of our clinical consultants, is quite remarkable and has the potential to help many more people than just the study population in our recently concluded Phase 3 clinical trial," stated CEL-SCI CEO, Geert Kersten. "In fact, these findings are so novel that we are currently preparing to file a new patent application. Details will be announced once the presentation has been given."
CEL-SCI’s IT-MATTERS pivotal Phase 3 study reported a statistically significant 14.1% absolute 5-year overall survival (OS) benefit in the intent to treat (ITT) subjects who received Multikine followed by surgery and radiotherapy, as compared to control subjects who received only standard of care (SOC) (surgery plus radiotherapy). The Company is pursuing marketing approval for Multikine in the treatment of head and neck cancer in the U.S., Canada and the European Union.