CEL-SCI is expanding the phase III clinical trial of its investigational cancer immunotherapy therapy, Multikine, to the U.K., Austria, Turkey, and Sri Lanka. The company hopes to enroll 880 patients in 20 countries by the end of 2015.
CEL-SCI has spent more than $12 million to develop Multikine since it launched trials in 2011.
The study is designed to determine if Multikine therapy administered before the current standard of care -- surgery plus radiotherapy or surgery plus concurrent radiochemotherapy -- for treating patients with head and neck cancer (HNC) will result in an increased overall rate of survival.
If Multikine goes on to prove successful in phase III trials, the company intends to apply to the U.S. Food and Drug Administration for use of the drug plus the current standard of care as a first-line treatment for head and neck cancer.
HNC drugs represent an estimated $3.6 billion market in the U.S. alone. Some 6% of all cancers are HNCs, with an estimated 650,000 new cases globally and about 150,000 in the U.S. and Europe.
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