CEL-SCI Submits Scientific Advice Filing to European Medicines Agency (EMA) for Multikine in the Treatment of Head & Neck Cancer
- Europe has 150,000 new annual cases of head and neck cancer, making it a high priority market for CEL-SCI.
- Positive clinical data from Phase 3 study to be discussed with the Scientific Advice Working Group.
- Goal is to obtain Working Group's opinion and reach an agreement for marketing authorization in the EU.
- None.
“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.”
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck (oral cavity and soft-palate) with the investigational product Multikine first, BEFORE they received surgery and radiotherapy or surgery plus concurrent radiotherapy and chemotherapy (the current standard of care for these patients). We believe this approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed.
Multikine is designed to help the immune system “target” the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. The Phase 3 study enrolled 928 patients.
Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.
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Forward-Looking Statements
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* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
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Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
Source: CEL-SCI Corporation
