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

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

August 22nd, 2011 // 12:13 pm @ jmpickett

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.

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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.

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Company has already taken actions

CEL- says it has already taken a series of actions to address the DDMAC letter, and has detailed the specific actions taken by the company to (a) revise the statements identified by the agency, (b) disseminate the revised statements and (c) identify the revised web pages on the CEL-SCI web site. Furthermore, its response letter describes additional actions that the company is implementing to ensure that its web site and the statements about the company’s R&D activities and investigational therapies on its web site are in full compliance with FDA (DDMAC) requirements related to drug promotion and advertising.

Chief executive Geert Kersten said: “CEL-SCI is fully committed to compliance with the law and to strict adherence with all governing laws, regulations, and policies, particularly those which are implemented and enforced by FDA, as well as those implemented and enforced by the other regulatory agency that shares significant regulatory oversight of our company, the Securities and Exchange Commission (SEC). Consistent with CEL-SCI’s longstanding compliance policies and procedures, CEL-SCI is particularly committed to assuring that statements regarding CEL-SCI’s investigational medicinal products such as those cited in DDMAC’s letter – which are directed at fulfilling our SEC-imposed disclosure obligations, while also engaging in a full exchange of scientific information and thereby advancing scientific knowledge and fostering scientific research in medical fields relating to products we are developing – are truthful, scientifically accurate, complete, and non-misleading. CEL-SCI’s commitment and approach in these regards apply equally to communications on-line as they do to all other forms of communication…We have now stepped up our proactive compliance initiatives to ensure that we remain within the regulatory framework for such scientific-information-exchange.”

Multikine, the company’s lead investigational product, is currently in a pivotal Phase III clinical trial. CEL-SCI is also developing an investigational immunotherapy (LEAPS-H1N1-DC) that is being evaluated for its potential to be used in the treatment of H1N1 hospitalized patients as well as an investigational vaccine (CEL-2000) that is being evaluated for rheumatoid arthritis (currently in preclinical testing) using its LEAPS technology platform.