CEL-SCI receives Polish government approval to commence Multikine Phase III clinical trial in head, neck cancer

CEL-SCI CorporationMay 5 2011

CEL-SCI Corporation (NYSE AMEX: CVM) announced today that it has received approval to begin enrollment of patients in its Phase III clinical trial of Multikine^® from the Polish Minister of Health. This approval marks a very important milestone, namely that all nine countries in the study have now given official government approval. Five of about 48 clinical centers for this global trial will be located in Poland. The global Phase III trial for Multikine was started in the United States in late December 2010 and in India in April 2011. CEL-SCI expects to commence the trial in other countries around the world in May and June 2011. Multikine is the Company's flagship immunotherapy developed as a first-line standard of care in the treatment of head and neck cancer.

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 chemo radiotherapy) in previously untreated 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 Phase III trial is expected to be the largest clinical study of head and neck cancer ever conducted. It is also the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. This is significant because conventional cancer therapy weakens the immune system and likely compromises the benefits of immunotherapy.

Phase II clinical trials of Multikine demonstrated that 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.