AsianScientist (Jun. 24, 2011) – CEL-SCI Corporation and its Taiwanese partner, Orient Europharma, have initiated Phase III clinical trials in Taiwan for CEL-SCI’s immunotherapy, Multikine®.
The Multikine to be used in the study is being delivered this week to Taiwan, and patient enrollment is expected to start soon. The first center will be the Shin Kong Wu Ho-Su Memorial Hospital in Taipei, Taiwan.
Named “IT-MATTERS” (Immunotherapy Multikine Anti Tumor Treatments), the goal of the trial is to establish Multikine as a first-line standard of care therapy in treating newly diagnosed head and neck cancer patients. The trial is believed to be the largest head and neck cancer study ever conducted.
Orient Europharma plans to sign up another six Taiwanese clinical centers to conduct this study, which is already ongoing at multiple clinical sites in the United States, Canada, Poland, Hungary and India.
The total study is expected to enroll about 880 head and neck cancer patients in over 40 hospitals in nine countries. CEL-SCI’s partner Teva Pharmaceuticals will conduct parts of the Phase III study in Israel.
Geert Kersten, CEO of CEL-SCI, said, “Taiwan has a large number of head and neck cancer cases due to the widespread use of betel nut, along with alcohol and smoking, which are common causes of head and neck cancer. We expect Taiwan to rapidly accelerate our overall patient enrollment as head and neck cancer represents a large unmet medical need in the country.”
CEL-SCI’s Phase III clinical trial is an open-label, randomized, controlled, multi-center study designed to determine if Multikine administered prior to current standard of care (surgery plus radiotherapy, or surgery plus concurrent radiochemotherapy) in naive subjects with head and neck cancer will result in an increased overall rate of survival versus the subjects treated with standard of care only.
It will also be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. A detailed description of the study can be found at http://clinicaltrials.gov/ct2/show/NCT01265849.
The U.S. Food and Drug Administration has already granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
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Source: CEL-SCI Corporation.
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