04:02 PM EDT, 05/08/2024 (MT Newswires) -- Cel-Sci ( CVM ) said Wednesday the US Food and Drug Administration indicated in a recent meeting that the company can move forward with a confirmatory registration study of its investigational cancer treatment Multikine.

The confirmatory trial needs to enroll 212 subjects and will be conducted in patients with newly diagnosed advanced primary head and neck cancer with no lymph node involvement and low programmed death-ligand 1 tumor expression, the company said.

The purpose of the study is to confirm positive results of the drug in a prospectively defined target population, the company said.

Cel-Sci ( CVM ) shares closed down 17% in the regular Wednesday session.

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