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CEL-SCI Presents Data at Prestigious Medical Conference Demonstrating That Its L.E.A.P.S. Technology Stimulates Maturation of Human Blood Cells Into Dendritic Cells Suggesting Potential for Prevention and Treatment of Infectious Disease
Date:4/27/2009

Technology also has potential to fight cancer, rheumatoid arthritis, as well as enhance the effectiveness of vaccines

VIENNA, Va., April 27 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE Amex: CVM) announced today the presentation of data at the 11th annual National Foundation of Infectious Diseases Conference in Baltimore which demonstrates how vaccines utilizing its L.E.A.P.S.(TM) (Ligand Epitope Antigen Presentation System) vaccine technology can induce protection against infectious disease, induce immunity against HIV, and promote immunotherapy for rheumatoid arthritis. 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. 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 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.

Dr. Rosenthal reported that within three days of treatment with either the anti-HSV or the anti-HIV L.E.A.P.S. vaccine, human blood cell monocytes purified from several different donors became mature dendritic cells. The transition was indicated by the expression of cell surface proteins, cell appearance and production of IL-12. Unlike monocytes treated with other maturation agents, the L.E.A.P.S. activated dendritic cells did not produce the inflammatory cytokines that are usually associated with IL-12 production. Untreated monocytes or monocytes treated with the HSV or HIV portion of the vaccine conjugate alone were unchanged and did not express any of the dendritic cell characteristics.

Dendritic cells direct the subsequent immune response to a vaccine by presenting the vaccine's antigen(s) to the appropriate T lymphocyte and then deliver specific cytokine proteins to the T cell to determine the immune response outcome to the specific vaccine. "L.E.A.P.S. vaccines are unique in their ability to interact with, activate and cause differentiation and maturation of dendritic cell towards a protective immune response without the production of pro-inflammatory cytokines," said Dr. Rosenthal.

The two lead product candidates being developed are CEL-1000 and CEL-2000 from the L.E.A.P.S. technology. CEL-1000 may have broad application for the enhancement of immune responses by individuals who have a poor immune response to vaccinations. It also has application for antigen sparing (reducing the amount/dose of antigen required for protective immunity), and to biodefense and pandemic settings for anti-infectious vaccines. CEL-2000, a L.E.A.P.S. vaccine incorporating a peptide from a rheumatoid arthritis disease protein, was shown to curtail the progression of tissue damage caused by rheumatoid arthritis.

"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. Dan Zimmerman, the inventor of the L.E.A.P.S. technology. "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."

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.

The concept behind the L.E.A.P.S. technology is to directly mimic cell/cell interactions on the dendritic and T-cell surface with synthetic peptides. The L.E.A.P.S. constructs containing the antigenic disease epitope linked to an Immune / T-cell binding ligand (I/TCBL) can be manufactured by peptide synthesis or by covalently linking the two peptides. Depending upon the type of L.E.A.P.S. construct and I/TCBL used, CEL-SCI is able to direct the outcome of the immune response towards the development of T-cell function with primarily effector T-cell functions (T Lymphocyte; helper/effector T lymphocyte, type 1 or 2 [Th1 or Th2], cytotoxic [Tc] or suppressor [Ts]). The L.E.A.P.S. vaccine constructs are chimeric peptides which combine antigen specificity with immune response modulation.

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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SOURCE CEL-SCI Corporation
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