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

The phase III trial will be run at about 48 clinical centres, of which 7 centres will be in Taiwan. The Taiwanese part of the study will be run and paid for by CEL-SCI's partner Orient Euro-pharma of Taiwan. A similar arrangement has been put in place with Teva Pharmaceuticals, another CEL-SCI partner for the phase III clinical trial, for centres that participate in the phase III trial in Israel.

CEL-SCI's phase III clinical trial is an open-label, randomized, multi-centre 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 tumours in 12 per cent 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 per cent 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 neo-adjuvant therapy of patients with squamous cell carcinoma of the head and neck.

CEL-SCI Corporation is developing products that empower immune defences. Its lead product is Multikine. In phase II clinical trials Multikine was shown to be safe and well-tolerated, and to improve the patients' overall survival by 33 per cent at a median of three and a half years following surgery. A pivotal Phase III clinical trial with Multikine in head and neck cancer is expected to start in the last quarter of 2010.