CEL-SCI Corporation has received governmental approval from the Hungarian National Institute of Pharmacy to begin enrolment of subjects for a phase-III clinical trial of Multikine in Hungary. Multikine is the company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. Hungary is one of nine countries to participate in this global phase-III trial.

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 enrolment of subjects and the study has been cleared by the US FDA.

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. CEL-SCI plans to announce additional approvals as they become known.

Phase II clinical trials of Multikine demonstrated the product was safe and well-tolerated and eliminated tumours 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' tumours 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 US 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.

CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine.