FDA issues clinical hold on CEL-SCI's head and neck cancer study with Multikine

CEL-SCI Corp (NYSE: CVM) says it has received verbal notice from the US Food and Drug Administration that its Multikine (leukocyte interleukin injection) Phase III clinical trial in advanced primary head and neck cancer has been placed on clinical hold.

As a result of this communication from FDA, patients currently receiving study treatments can continue to receive treatment, and patients already enrolled in the study will continue to be followed. CEL-SCI was also told to expect a formal letter from the FDA within 30 days and will work diligently with the FDA to obtain the release of the clinical hold. The study currently has about 926 patients enrolled.

Last October, UK provider of development services to drugmakers, Ergomed (AIM: ERGO) said it will pay $12 million for the Phase III trial for drug to treat to head and neck cancer following an expanded agreement with CEL-SCI.