Business
CEL-SCI to File for Regulatory Approval of Multikine in Saudi Arabia—Pursuing Local Partnerships for Commercialization and Manufacturing to Serve Middle East and North Africa Market
VIENNA, Va., April 23, 2025--CEL-SCI to file for Regulatory Approval of Multikine in Saudi Arabia—Pursuing local partnerships to serve Middle East and North Africa Market
About this update from Cel-sci Corporation
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":240,"url":"https://media.zenfs.com/en/business-wire.com/db9a697930bc210a847cd750c4bb5350"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/aqvKHC1rStVjgcQWukPt6Q--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQ4MDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/db9a697930bc210a847cd750c4bb5350","width":480,"height":240}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"Concluded a successful meeting with Saudi Food and Drug Authority","length":65,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"CEL-SCI was encouraged to apply for Conditional Approval with Breakthrough Therapy Designation based on data from its concluded Phase 3 study","length":141,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Evaluating Saudi Arabia-based partnerships to potentially fund local manufacturing and launch Multikine throughout the region","length":125,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":331,"olType":false},{"type":"text","content":"VIENNA, Va., April 23, 2025--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced that it met with the Saudi Food and Drug Authority (SFDA) to discuss the development of Multikine cancer immunotherapy* (Leukocyte Interleukin, Injection), the vast amount of Multikine data available to support a marketing application for its use as a treatment of head and neck cancer, and the possible pathways to a marketing application in Saudi Arabia.","length":459,"tagName":"p"},{"type":"text","content":"Based on discussions with the SFDA, CEL-SCI is preparing to submit a regulatory filing for the approval of Multikine as a neoadjuvant (pre-surgical) treatment of newly diagnosed previously untreated locally advanced head and neck cancer. The submission will be made based on all data from CEL-SCI’s concluded 928-patient randomized controlled Phase 3 study and is expected to be filed as a Conditional Approval with Breakthrough Therapy designation. The SFDA’s usual response time for a complete submission for such an application is thought to be approximately 60 days after filing.","length":583,"tagName":"p"},{"type":"text","content":""Our data was well received by the SFDA in a rece...