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CEL-SCI And NIAID Publish Data Showing That CEL-SCI’s LEAPS Technology Halted Progression Of Lethal Influenza In Three Different Influenza Virus Strains, Including A Drug-Resistant And A 2009 Pandemic Flu Strain

CEL-SCI Corporation (NYSE MKT: CVM) announces the publication of the results of influenza studies by researchers from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) and CEL-SCI in the Journal of Clinical Investigation, a leading journal for discoveries in basic and clinical biomedical research (2013 J Clin Invest. doi: 10.1172/JCI67550 2013, supplemental information at www.jci.org/articles/view/67550). The studies described in the publication show that when CEL-SCI’s investigational J-LEAPS Influenza Virus treatments were used “in vitro” to activate immune cells called dendritic cells (DCs), these activated dendritic cells, when injected into influenza infected mice, arrested the progression of lethal influenza virus infection in these mice. The work was performed in the laboratory of Kanta Subbarao, M.D., Chief of the Emerging Respiratory Diseases Section in NIAID’s Division of Intramural Research.

This work is particularly important because it involved influenza strains that are drug-resistant and because the protection is achieved by significantly reducing the number of inflammatory immune cells in the lungs, a significant contributor to death from certain influenza viruses. The investigators state in the article: “ Our data demonstrate that Influenza-J-LEAPS-pulsed DCs reduce virus replication in the lungs, enhance survival, and modulate the protective immune responses that eliminate the virus while preventing excessive cytokines that could injure the host. This approach shows promise as an adjunct to antiviral treatment of influenza virus infections.”

In a mouse model of influenza virus infection having an ongoing and established disease process, the administration of activated J-LEAPS-DCs for up to several days following the initiation of influenza virus infection prevented morbidity and mortality as evidenced by the measurement of several key disease associated parameters: (1) the mice did not lose weight, (2) virus production was significantly reduced in treated mice, and (3) in general, there was less inflammatory immune response present, as indicated by a decrease of the inflammatory immune responses in the lungs of infected mice treated with J-LEAPS-DCs, all as compared to controls. J-LEAPS-DC treatment of the infected mice also prevented the over production of inflammatory cytokines. The prevention of the over production of inflammatory cytokines, something also called “cytokine storm”, could also be very important clinically because the over production of inflammatory cytokines is often associated with a worsening of the clinical condition of these patients, which may lead to death. A new and separate NIAID study in mice shows that excessive early immune responses contribute to deaths caused by certain influenza viruses. Scientists found that reducing the number of inflammatory immune cells in the lungs of mice increased the animals' survival after infection with a virulent flu strain. The researchers, led by Marlène Brandes, M.D., Ph.D., and Ronald Germain, M.D., Ph.D., of NIAID's Laboratory of Systems Biology (LSB), reported their results in the July 3, 2013, issue of Cell.

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