CEL-SCI Corporation (NYSE AMEX: CVM) announced today it has received approval from seven hospital Institutional Review Boards ("IRB") in India to begin enrollment of subjects for a Phase III clinical trial of Multikine®, the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. An IRB is a group formally designated by an institution to review and monitor research involving human subjects and to ensure protection of their rights and welfare. CEL-SCI expects to have fifteen clinical centers in India, out of an expected forty-eight clinical centers world-wide. Head and neck cancer is the most prevalent form of cancer in India with about 200,000 new patients annually.
CEL-SCI's Phase III clinical trial is an open-label, randomized, multi-center study designed to determine if Multikine administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Chemo radiotherapy) in subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival versus the subjects treated with standard of care only. North Mississippi Health Services was the first site in the United States to approve enrollment of subjects.
CEL-SCI's trial will be conducted in nine countries and is expected to be the largest clinical study of head and neck cancer ever conducted. It will also be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. CEL-SCI plans to announce additional site approvals and country approvals as they become known.
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. The Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects' tumors before the start of standard therapy. 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 U.S. Food and Drug Administration gave clearance for a Phase III clinical trial and 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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