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CEL-SCI Expands Testing of Its Vaccine to Determine Efficacy Against More Virulent Strain of H1N1 Swine and Other Influenza Viruses


VIENNA, Va., June 9 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE Amex: CVM) announced today that it is expanding the pre-clinical testing of its flu vaccine, utilizing its proprietary L.E.A.P.S. technology (Ligand Epitope Antigen Presentation System) to determine its efficacy against the more dangerous and virulent virus strains that may arise during the up coming winter flu season. The Company has begun pre-clinical formulation, evaluation and testing of a new application of its L.E.A.P.S vaccine, which will allow the targeting of "mutated" versions of H1N1 swine and other influenza viruses. It is believed that the influenza virus may mutate and evolve between now and the winter flu season. In conjunction with the testing, CEL-SCI has produced several L.E.A.P.S. flu vaccines that focus on the conserved, non changing epitopes of the different strains of Type A Influenza viruses (H1N1, H5N1, H3N1, etc.), including "swine", "avian or bird", and "Spanish Influenza", in order to minimize the chance of viral "escape by mutations" from immune recognition. CEL-SCI's L.E.A.P.S. flu vaccine contains epitopes known to be associated with immune protection against influenza in animal models. The Company had previously announced that it had begun pre-clinical testing of swine and H1N1 flu viruses, which were non-mutated versions of the virus.

The use of L.E.A.P.S. vaccine technology for immunization in animal models has already been shown to provide protection from viral diseases without causing an immune response associated with the deadly "cytokine-storm" seen in many of the victims of influenza.

Dr. Daniel Zimmerman, inventor of the L.E.A.P.S. technology, and currently a consultant to CEL-SCI, said, "Various L.E.A.P.S. technology constructs have already been shown to induce protection in animal challenge models against a variety of diseases such as malaria and herpes simplex virus and as therapeutic vaccines in two different autoimmune conditions. Data showed that L.E.A.P.S. vaccines were able to induce these protective immune responses without the excessive induction of pro-inflammatory cytokines. This is thought to be very important in the swine flu, or the avian flu, since it appears that the excessive production of pro-inflammatory cytokines during the course of the disease is responsible for and may lead to the increased number of deaths from these illnesses."

Recently, 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. 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 and spleen cells from immunized mice produced gamma interferon in response to the vaccine, while the cells from mice in the various control groups did not.

The 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. Each L.E.A.P.S. construct is composed of a T cell binding ligand (TCBL) which has previously demonstrated the ability to induce and elicit protective immunity and antigen specific antibody production in animal models.

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 currently 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.

SOURCE CEL-SCI Corporation
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