CEL-SCI Receives Green Light From FDA to Proceed With Phase III Cancer Study
CEL-SCI Corporation announced that the U.S. food and Drug Administration (FDA) has stated in a letter to the Company that, "...the proposed Phase III study may proceed at any time." CEL-SCI's Phase III clinical study is designed to prove that its cancer drug Multikine(R) increases the survival of head and neck cancer patients.
The study is expected to be conducted in numerous countries around the world. It is designed to develop conclusive evidence of the efficacy of the Multikine treatment regimen in advanced primary squamous cell carcinoma of the oral cavity (head and neck cancer). Upon successful completion of this study, the data will be included in CEL-SCI's worldwide Marketing Applications to make Multikine commercially available for the treatment of this patient population.
Geert Kersten, Chief Executive Officer of CEL-SCI, said, "So far Multikine has been shown to be non-toxic, which is very unusual for a cancer drug. In Phase II clinical studies with head and neck cancer patients it also markedly increased survival. Now we will get the chance to prove that Multikine can extend the survival of these cancer patients."
The global Phase III study will test the hypothesis that the Multikine treatment regimen, administered locally prior to the current standard therapy given to patients with advanced primary squamous cell carcinoma of the oral cavity, will extend the overall survival and enhance the local/regional control of the disease, while increasing disease free survival in these patients.
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