The Canadian regulatory agency has agreed to give the study the go-ahead, following Cel-Sci’s application submitted last month. The company hopes to recruit about 500 patients 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 license to market Multikine for the treatment of this patient population.
The trial will test the hypothesis that Multikine treatment administered prior to the current standard therapy for head and neck cancer patients 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.
“Multikine has an anti-tumor mechanism of action that is different from the current cancer therapies and may enhance the success of radiotherapy and chemotherapy,” said Geert Kersten, CEO of Cel-Sci.