The Canadian regulatory agency, the Biologics and Genetic Therapies Directorate, has concurred with the initiation of a global Phase III clinical trial of CEL-SCI Corporation in head and neck cancer patients using CEL-SCI's immunotherapy drug Multikine. The formal "no objection" letter from the regulatory agency to the Clinical Trial Application (CTA), which was submitted last month, enables CEL-SCI to initiate the Canadian arm of the Phase III Multikine trial.

About 500 patients will be enrolled worldwide in the Phase III trial. The protocol is designed to develop conclusive evidence of the efficacy of Multikine in the treatment of advanced primary squamous cell carcinoma of the oral cavity (head and neck cancer). A successful outcome from this trial should enable CEL-SCI to apply for a Biologics License to market Multikine for the treatment of this patient population, according to a company release.

The trial will test the hypothesis that Multikine treatment administered prior to the current standard therapy for head and neck cancer patients (surgical resection of the tumour and involved lymph nodes followed by radiotherapy or radiotherapy and concurrent chemotherapy) will enhance the local/regional control of the disease, reduce the rate of disease progression and extend the time of progression free survival in patients with advanced oral squamous cell carcinoma.

Geert Kersten, CEO of CEL-SCI, said, "Multikine has an anti-tumour mechanism of action that is different from the current cancer therapies and may enhance the success of radiotherapy and chemotherapy. We believe that the addition of Multikine to the current standard therapy for advanced primary squamous cell carcinoma of the oral cavity should result in further clinical benefit to these patients, without additional toxicity."

Head and neck cancer is an aggressive cancer that affects about 500,000 people per annum worldwide.