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news.CEL-SCI has commenced Phase III clinical trial Immunotherapy Multikine Anti Tumor Treatments (IT-MATTERS) to establish Multikine as a first-line standard of care therapy in treating newly diagnosed head and neck cancer patients.
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Phase II clinical trials of Multikine demonstrated the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment.
CEL-SCI said it has now completed all of the manufacturing and regulatory requirements to begin enrollment of the open label, randomized, controlled trial in which patients are prospectively stratified.
The company plans to enroll approximately 880 patients at about 48 clinical centers in 9 countries (USA, Canada, Hungary, Poland, Ukraine, Russia, India, Israel and Taiwan) in the IT-MATTERS trial.
CEL-SCI’s partners Teva Pharmaceuticals and Orient Europharma will conduct parts of the Phase III study in Israel and Taiwan respectively.
All study sites, including those in Israel and Taiwan, are under the control of CEL-SCI’s global clinical research organization.