CEL-SCI Receives Phase III Clinical Trial Go-Ahead for Cancer Drug
8/24/2005 Vienna, VA press release PRNewswire (prnewswire.com) CEL-SCI CORPORATION announces that it has achieved one of its most significant milestones to date. The Canadian regulatory agency, the Biologics and Genetic Therapies Directorate, has concurred with the initiation of a global Phase III clinical trial in head and neck cancer patients using CEL-SCI's immunotherapy drug Multikine(R), the Company's lead product. The formal "no objection" letter from the BGTD 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. 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 tumor 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, Chief Executive Officer of CEL-SCI, said, "Multikine has an anti-tumor mechanism of action that is different from the current cancer therapies [...]