WARNING LETTER. Multikine is an investigational new drug that does not have marketing authorization in the United States. (b) (4)

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1 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD TRANSMITTED BY FACSIMILE Geert R. Kersten Director and Chief Executive Officer 8229 Boone Boulevard, Suite 802 Vienna, VA RE: (b) (4) Multikine (Leukocyte Interleukin) Injection MACMIS #19732 WARNING LETTER Dear Mr. Kersten: The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed s (Cel-Sci) Home Page and CEL-SCI web pages titled, Combination Immunotherapy, Introduction to Multikine, Multikine s uses, efficacy and clinical trial status, Multikine Tumor Pictures, and Multikine Key Benefits for your investigational new drug Multikine (Leukocyte Interleukin) Injection (Multikine) found at and 1 The web pages contain claims that promote Multikine, an investigational new drug, as safe and effective for the purposes for which it is being investigated. As a result, the web pages violate the Federal Food, Drug, and Cosmetic Act (the Act) and FDA implementing regulations. 21 CFR 312.7(a). This is concerning from a public health perspective because it 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. Background Multikine is an investigational new drug that does not have marketing authorization in the United States. (b) (4) Promotion of an Investigational New Drug Promotion of an investigational new drug is prohibited under FDA regulations at 21CFR 312.7(a), which states, A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to 1 Last accessed July 19, 2011.

2 Geert R. Kersten Page 2 restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution. The web pages contain claims such as the following that promote Multikine as safe and/or effective for the purposes for which it is being investigated or otherwise promote the drug. (bolded emphasis in original; underline emphasis added): Multikine is non-toxic because it works with the body s immune system. CEL SCI home page Multikine is the first combination immunotherapy. It is the only immunotherapy that is able to directly affect both the tumor cells themselves and activate a robust anti-tumor immune response. Combination Immunotherapy page Multikine has been shown to be safe and well tolerated and is non-toxic to healthy cells. Introduction to Multikine page Multikine unleashes and then harnesses and enhances the immune system s ability to target and kill those tumor cells before they can cause recurrence or metastasize. Multikine s uses, efficacy and clinical trial status page Efficacy seen in clinical trials conducted with Multikine : o 33% improvement in median overall survival: In Phase II studies an impressive 33% improvement in median overall survival at a median of 3.5 years post surgery was seen in patients with locally advanced disease treated with Multikine as first-line therapy (absolute survival rate 63%) over the 3.5 year median overall survival rates of the same cancer patient population determined from a review of 55 clinical trials reported in the scientific literature that were conducted between 1987 and To put this in context, most cancer blockbusters have been approved on a 10% increase in overall survival, so a 33% improvement over what can be expected from the current therapy is considered extraordinary." Multikine s uses, efficacy and clinical trial status page The Multikine Tumor Pictures web page presents three case studies using before and after images of patients treated with Multikine for head and neck cancer. The images depict dramatic improvements in all three cases and are accompanied by claims such as the following: o After 3 months of treatment with Multikine, no evidence of tumor was observed, either visually or by palpation. o During the course of 2 treatment cycles with Multikine in 42 days, the plum sized tumor virtually disappeared.

3 Geert R. Kersten Page 3 First Line treatment Advantages: Multikine (following approval) would be part of standard of care for every head and neck cancer patient s initial treatment. This means every patient diagnosed with the disease should receive Multikine." Multikine Key Benefits page Furthermore, because Multikine is made from healthy donors immune system cells and is readily available as a ready-to-use anti-cancer immunotherapy, it can be administered to any patient immediately and without delay. Multikine Key Benefits page These claims suggest that Multikine, an investigational new drug, 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. Additionally, the totality of the above-referenced claims suggest that the drug is non-toxic, and has demonstrated impressive and extraordinary improvements in overall survival over what can be expected from the current therapy. Since Multikine is an investigational new drug, the product s indication(s), warnings, precautions, adverse reactions, and dosage and administration have not been established and are unknown at this time. Cel-Sci s promotion of Multikine as safe and effective for the purposes for which it is under investigation, by making representations such as those noted above, is in violation of 21 CFR 312.7(a). Conclusion and Requested Actions For the reasons discussed above, the web pages violate the Act and FDA implementing regulations. 21 CFR 312.7(a). DDMAC requests that CEL-SCI immediately cease the dissemination of violative promotional materials for Multikine such as those described above. Please submit a written response to this letter on or before August 19, 2011, stating whether you intend to comply with this request, listing all promotional materials for Multikine that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials. Because the violation described above is serious, we request, further, that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials. In order to clearly identify the violative promotional piece(s) and/or activity and focus on the corrective message(s), DDMAC recommends that corrective piece(s) include a description of the violative promotional piece(s) and/or activity, include a summary of the violative message(s), provide information to correct each of the violative message(s), and be free of promotional claims and presentations. To the extent possible, corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated. Please direct your response to me at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD , facsimile at In all

4 Geert R. Kersten Page 4 future correspondence regarding this matter, please refer to MACMIS #19732 in addition to the (b) (4). We remind you that only written communications are considered official. The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for your investigational new drug Multikine comply with each applicable requirement of the Act and FDA implementing regulations. Failure to correct the violation discussed above may result in FDA regulatory action, including seizure or injunction, without further notice. Sincerely, {See appended electronic signature page} Thomas W. Abrams, RPh, MBA Director Division of Drug Marketing, Advertising, and Communications

5 This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature /s/ THOMAS W ABRAMS 08/05/2011