WASHINGTON — Vienna, Virginia-based biotechnology company Cel-Sci, currently running late-stage clinical trials with patients for its head and neck cancer treatment, watched its stock fall more than 30 percent in early Tuesday trading after a notice from the Food and Drug Administration.
Cel-Sci said it has received a verbal notice from the FDA that its Multkine Phase 3 trials have been placed on clinical hold. Cel-Sci did not say why.
The company said it also was told to expect a formal letter from the FDA in the next 30 days, and it will work diligently with the FDA to obtain the release of the clinical hold.
Cel-Sci’s clinical trial with humans is the largest of its kind with head and neck cancer patients. It currently involves 926 patients enrolled in 24 countries.
Cel-Sci says those patients will continue to receive study treatments and will continue to be followed.
On Sept. 6, Cel-Sci announced that its 87-year-old founder, president and chairman, Maximilian de Clara resigned for personal health reasons.
Last month, the company raised $5 million from investors to fund its ongoing clinical studies and research.
Cel-Sci stock (NYSE: CVM) finished Tuesday trading down 17 cents, or 39 percent, to 27 cents per share.
