CEL-SCI receives no objection letter to initiate Phase III clinical trial of Multikine in Canada

Apr 30 2011

CEL-SCI Corporation (NYSE AMEX: CVM) announced today that the Biologics and Genetic Therapeutics Directorate of Health Canada has issued a final "no objection" letter for CEL-SCI to be able to begin enrollment of patients for a Phase III clinical trial of Multikine^® in Canada. This final approval was given after CEL-SCI was able to provide facility, manufacturing and stability data for the clinical batches of Multikine. Canadian centers are expected to start enrolling patients within the next month.

The Phase III trial will be conducted in approximately 48 clinical centers in nine countries. CEL-SCI's partner Teva Pharmaceutical Industries will be conducting the trial at three clinical centers in Israel and its partner Orient Europharma will be conducting the trial at seven clinical centers in Taiwan. The Phase III trial started in the United States in late December 2010 and in India on April 28, 2011. Multikine is the Company's flagship immunotherapy developed as a first-line standard of care in treating 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.

SOURCE CEL-SCI Corporation