CEL-SCI receives Ukraine government approval for Multikine Phase III clinical trial in head and neck cancer

Dec 16 2010

CEL-SCI Corporation (NYSE AMEX: CVM) announced today it has received governmental approval from the Health Authority, Ministry of Health of Ukraine, to begin enrollment of subjects for a Phase III clinical trial of Multikine^® in Ukraine. Multikine is the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. Ukraine is one of nine countries to participate in this global Phase III trial. 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 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. CEL-SCI's 880 patient trial 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.

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 granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.

Source CEL-SCI Corporation