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news.CEL-SCI has received governmental approval from the Health Authority, Ministry of Health of Ukraine, to begin enrollment of subjects for an open-label, randomized, multi-center study Phase III clinical trial of Multikine in Ukraine.
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CEL-SCI claims that Multikine is its immunotherapy developed as a first-line standard of care in treating head and neck cancer.
The Phase III trial will be run at about 48 clinical centers, of which about 6 centers will be in Ukraine.
CEL-SCI’s Phase III clinical trial is designed to determine if Multikine administered prior to current standard of care in subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate will result in an increased overall rate of survival versus the subjects treated with standard of care only.
The 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.
Follow-up studies of subjects enrolled in Phase II trials showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery.
The US Food and Drug Administration (FDA) granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.