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
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Concluded a successful meeting with
Saudi Food and Drug Authority -
CEL-SCI - Evaluating Saudi Arabia-based partnerships to potentially fund local manufacturing and launch Multikine throughout the region
Based on discussions with the SFDA,
“Our data was well received by the SFDA in a recent meeting. In consideration of their response, our intention is to file for Conditional Approval of Multikine with Breakthrough Therapy designation based on our completed Phase 3 data,” stated
“In alignment with the Saudi Kingdom’s Vision 2030 initiatives, we are currently evaluating potential partnerships with local Saudi companies to commercialize Multikine, conduct clinical trials in Saudi hospitals and to establish a local Multikine manufacturing facility that would serve the entire
The Kingdom of Saudi Arabia’s Vision 2030 includes a National Biotechnology Strategy, which is poised to position the Kingdom as a regional and global biotech hub with a far-reaching impact in biomanufacturing and medical innovation. The National Biotechnology Strategy aims to establish an advanced local bio-manufacturing platform to boost the Kingdom’s self-sufficiency in producing biologics and biosimilars, enable global export opportunities, drive growth of the broader biotech sector in the Kingdom, and reduce healthcare costs.
The incidence of head and neck cancer in the MENA region is expected to double by 2030, from incidence levels cited in a 2012 study. This rate of increase is two times higher than that of the projected worldwide incidence rate. In the
About
Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually.
The Company has operations in
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital, inability to finalize a partnering agreement and the risk factors set forth from time to time in
* Multikine (Leukocyte Interleukin, Injection) is the trademark that
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