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CEL SCI Collaborators Demonstrate Novel L.E.A.P.S. Vaccines Immunize Mice Against Tuberculosis Antigens and Suggest Potential to Treat Swine and Other Influenzas
Date:6/5/2009

VIENNA, Va., June 5 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE AMEX: CVM) announced today that its collaborators at the University of Hawaii reported on data at the annual American Society for Microbiology in Philadelphia, PA. This data demonstrates that vaccines utilizing its L.E.A.P.S.(TM) (Ligand Epitope Antigen Presentation System) vaccine technology with specificity for particular Mycobacterium tuberculosis (TB) antigens can elicit immune responses that would be protective against tuberculosis and have the potential to treat swine and other H1N1 influenzas.

The investigators presented data that showed that blood cells from immunized mice produced gamma interferon in response to the vaccine, while the blood cells from mice in the various control groups did not. Gamma interferon, a cytokine that helps regulate the body's immune response, is considered to be a good indicator of protection against TB and other diseases. The production of too many pro-inflammatory cytokines is thought to be a cause of death in the case of H1N1 influenza. It is for this reason that CEL-SCI believes that the L.E.A.P.S. technology, which induces an effective protective immune response without causing excessive amounts of pro-inflammatory cytokines, may be effective against H1N1 influenza.

In prior tests involving L.E.A.P.S. herpes simplex vaccines, CEL-SCI and other researchers showed that the production of gamma interferon was a good indicator for protection against herpes simplex as well. Dr. Borthakur, of the University of Hawaii, reported at the Microbiology Conference that mouse blood cells taken from L.E.A.P.S. TB immunized mice made detectable amounts of gamma interferon within one day of treatment.

Dr. Daniel Zimmerman, the inventor of the technology believes that the data presented by Dr. Borthakur's group will also be beneficial in developing more improved TB vaccines, perhaps ones including the L.E.A.P.S. conjugates known to elicit protective cytokines such as IL-12, a precursor to producing gamma interferon, and gamma interferon itself.

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 a herpes simplex virus (HSV) glycoprotein to make a vaccine that induces a defined immune response. Last month Dr. Kenneth S. Rosenthal, Professor of Microbiology, Immunology and Biochemistry at Northeastern Ohio Universities Colleges of Medicine and Pharmacy and colleagues showed that CEL-SCI's L.E.A.P.S. vaccines can activate and cause human immature dendritic cells from blood monocyte cells to become dendritic cells that secrete the IL-12 cytokine. The dendritic cells that result initiate a protective cell mediated and antibody immune response. These results were obtained for L.E.A.P.S. vaccines against HSV and HIV. The use of the L.E.A.P.S. vaccine technology may thus open a whole new way of maturing dendritic cell vaccines for infectious diseases such as pandemic flu and cancer. The cytokine IL-12 is the first step in gamma interferon production which is known to be protective with many viruses and pathogens.

"It is very exciting to see the effect of L.E.A.P.S. vaccines on isolated human immature dendritic cells using a simple molecule, in two different instances," said Dr. Zimmerman. "I am hopeful that other L.E.A.P.S. vaccine candidates, such as CEL-2000 being developed as a vaccine for rheumatoid arthritis, can also be used with comparable results in humans. The lack of proinflammatory cytokine production in responses to the L.E.A.P.S. vaccines is especially important for an immunotherapy aimed at rheumatoid arthritis, since these cytokines cause much of the damage seen in rheumatoid arthritis patients, and has important implications for our ability to develop an effective treatment for swine flu and other H1N1 flu viruses."

L.E.A.P.S. technology is a novel T-cell modulation platform technology that enables CEL-SCI to design and synthesize proprietary immunogens. Any disease for which an antigenic sequence has been identified, such as infectious, parasitic, malignant or autoimmune diseases and allergies, are potential therapeutic or preventive sites for the application of L.E.A.P.S. technology.

CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine(R) which is being readied for a global Phase III trial. The Company has operations in Vienna, Virginia, and Baltimore, Maryland.

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: an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, 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, 2008. 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.


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