Positive results from CEL-SCI's LEAPS H1N1-activated dendritic cells trial in mice

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."