CEL-SCI rockets on response to FDA clinical hold

CEL-SCI Corp (NYSE: CVM) saw its shares leap 29.35% to $0.10 by close of trading on Monday after it said it has responded to the US Food and Drug Administration’s most recent communication from May 2017 about the clinical hold imposed on the company’s Phase III head and neck cancer study with Multikine (leukocyte interleukin, injection).

The hold issues addressed in the FDA communication were that the study’s Investigator Brochure (IB) and the “Dear Investigator” letter need to be revised. Specific deficiencies and their locations in each of the documents were identified, and directions were given as to the specific information that should be included in the revisions of these documents. CEL-SCI revised the documents exactly as directed by the FDA. If the FDA finds the revisions made to the two documents to be satisfactory, CEL-SCI is hopeful that all of the clinical hold issues have now been addressed, and the FDA will consider lifting the clinical hold.

As of September 2016, 928 head and neck cancer patients have been enrolled and have completed treatment in the Phase III study. In accordance with the study protocol, the FDA’s instructions, and subject to the clinical hold, CEL-SCI continues to follow these patients.