CEL-SCI gets FDA warning letter about web site statements on Multikine

US drug developer CEL-SCI Corp (NYSE AMEX: CVM) says it received a warning letter received from the Division of Drug Advertising Marketing and Compliance (DDMAC) of the US Food and Drug Administration earlier this month regarding certain statements made about the company’s investigational therapy Multikine (leukocyte Interleukin, Injection) on its corporate web site and has responded.

The letter identifies specific statements on various pages of the CEL-SCI web site as promoting this investigational therapy as safe and effective for the purposes for which it is being investigated. Specifically, it noted that the web posting suggests “Multikine is safe and effective when the product has not been approved by the FDA and the promotional claims made have not been demonstrated by substantial evidence or substantial clinical experience.” These claims suggest that Multikine is safe and/or effective for the treatment of various kinds of cancers, including those of the head and neck, when it has not been approved for these uses, the letter stated.

Company has already taken actions