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CEL-SCI Corporation Study Shows LEAPS Dendritic Cell Therapy to Be Effective in Treating H1N1 Virus

VIENNA, Va.--(BUSINESS WIRE)--May 26, 2011 - CEL-SCI Corporation (NYSE Amex: CVM) today announced the positive results of efficacy studies in mice of L.E.A.P.S.TM (Ligand Epitope Antigen Presentation System) H1N1 activated dendritic cells (DCs) to treat the H1N1 virus. Scientists found that H1N1-infected mice treated with LEAPS-H1N1 DCs showed a survival advantage over mice treated with control DCs. The work was performed in collaboration with scientists led by Kanta Subbarao, M.B.B.S., M.P.H, of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, USA. The study results were announced during the Keystone Conference on “Pathogenesis of Influenza: Virus-Host Interactions” in Hong Kong, China.

An important observation made in this study was that the LEAPS H1N1-activated DCs were drawn to and concentrated at the lungs, where they were most needed to combat the infecting virus, and were not dissipated throughout the body. Control DCs (DCs not pre-activated with LEAPS) did not localize to the lungs of the infected mice. In a different model, it was shown that LEAPS-activated DCs do not cause secretion of the type of inflammatory cytokines usually associated with “cytokine storm”. Thus this treatment may be useful in the treatment of influenza-infected individuals. The specific and selective behavior of LEAPS-activated DCs could be used in the treatment and mitigation of many other infectious diseases such as pandemic viruses and even cancer and autoimmune conditions.

The study involved infecting mice with a mouse-adapted influenza virus strain and treating these mice at various times after infection with mouse DCs pretreated with LEAPS H1N1. LEAPS H1N1 pre-treated DCs used as treatment for infected mice resulted in survival advantage over control-DC-treated mice. Similar efficacious findings were observed for both body weight and viral isolation (titer) from the lungs of infected mice after treatment with LEAPS H1N1 DCs as opposed to control DCs. The localization of the LEAPS H1N1-activated DCs was observed using labeling procedures, allowing the tissue localization of the DCs used as treatment. Labeled DCs not activated with LEAPS H1N1 did not become localized to the site of influenza infection (the lung), while LEAPS H1N1 pre-treated DCs preferentially localized to the infected lungs. Mouse DCs were also observed undergoing a number of morphological, phenotype and functional changes similar to those previously reported by CEL-SCI and its collaborators.

Daniel H. Zimmerman, Ph.D., Senior Vice President at CEL-SCI and the co-inventor of the L.E.A.P.S. technology said, “These exciting findings open up the field for activated autologous DC therapy and the LEAPS technology. These studies using LEAPS-activated dendritic cells are in many ways similar in nature and treatment approach to autologous vaccines used to treat cancer. The LEAPS molecules, however, are much less expensive, easier to make and use, and are more universal (not patient-specific) than autologous products.”

CEL-SCI's LEAPS technology directs an immune response against specific disease epitopes. In the case of CEL-SCI's LEAPS H1N1 treatment, this involves non-changing regions of H1N1 pandemic flu, H5N1 avian flu, and the 1918 pandemic flu. This activity is intended to enable stimulation of the specifically needed immune responses, while avoiding the administration of regions of H1N1, and other viruses, which may exacerbate potential problems such as a “cytokine storm”, which CEL-SCI scientists believe to be involved in, or contribute to, the death of some H1N1 patients.

L.E.A.P.S. technology is a novel T-cell modulation platform technology that enables CEL-SCI to design and synthesize non-recombinant, proprietary immunogens. The L.E.A.P.S technology combines a small peptide that activates the immune system with a small peptide from a disease-related protein, such as the H1N1 hemagglutinin molecule, to make an investigational product that induces defined immune responses.

About CEL-SCI Corporation

CEL-SCI Corporation is developing products that empower immune defenses. Its lead product, Multikine® is currently being tested in a global Phase III clinical trial in head and neck cancer that started in December 2010. In Phase II clinical trials Multikine was shown to be safe and well-tolerated and to improve the patients overall survival by 33 percent at a median of three and half years following surgery. CEL-SCI is also developing a vaccine (CEL-2000) for Rheumatoid Arthritis using its L.E.A.P.S. technology platform. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.

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When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, lack of regulatory clearance to proceed with clinical trials, an inability to duplicate the clinical results demonstrated in clinical studies that have been completed or that are initiated in the future, timely development of any potential products that can be shown to be safe and effective, unwillingness of regulatory authorities to engage in further regulatory dialogue, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital, and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10-K/A for the year ended September 30, 2010. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.


Contact: CEL-SCI Corporation
Gavin de Windt, 703-506-9460



Posted: May 2011