CEL-SCI Files Patent Application To Support Company's Treatment For More Virulent Strain Of H1N1 Swine And Other Influenza Viruses

Main Category: Swine Flu
Also Included In: Immune System / Vaccines
Article Date: 25 Jun 2009 - 2:00 PDT

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CEL-SCI CORPORATION (NYSE AMEX: CVM) announced that it has filed a provisional U.S. patent application covering its L.E.A.P.S.(TM) immune therapy drugs (vaccines) for the prevention/treatment of H1N1, swine, bird flu, Influenza A and/or evolving mutants or variants of these viruses. Some experts believe that by the next flu season the swine flu virus will have evolved and/or combined with other viruses to create a much more lethal new virus. That is what happened in the case of the Spanish flu pandemic. CEL-SCI's efforts to fight this virus are focused on using conserved epitopes from essential proteins to be found in the A influenza virus for H1N1, H1N5, swine, bird flu and Spanish influenza to create an effective vaccine/treatment that could potentially fight such a mutant virus.

Geert Kersten, Chief Executive Officer of CEL-SCI said, "By filing this provisional patent in the U.S., we are preserving our rights to file patents on these inventions and for their use world-wide either as an injected vaccine before a person is infected or exposed or as a therapeutic vaccine for treatment."

Experimental work has been initiated on these various methods of use and applications for the A influenza vaccines. These L.E.A.P.S. vaccines, when used individually or together, are expected to induce antigen specific immune response(s) which, based on other L.E.A.P.S. animal tests in multiple disease models will hopefully lead to a protective immune response.

The most recent such presentation by an outside university investigator (Dr. Borthakur, University of Hawaii) reported new L.E.A.P.S. Tuberculosis data at the Annual American Society for Microbiology in Philadelphia, PA. This TB data demonstrated that vaccines utilizing the L.E.A.P.S. vaccine technology with specificity for particular Mycobacterium tuberculosis (TB) antigens can elicit immune responses that would be expected to be protective against tuberculosis and have the potential to treat swine and other H1N1 influenzas. The TB 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. Other recent L.E.A.P.S. data, presented by Dr. Kenneth S. Rosenthal, Professor of Microbiology, Immunology and Biochemistry at Northeastern Ohio Universities Colleges of Medicine and Pharmacy and colleagues at the 12th NFID meeting in Baltimore 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 herpes simplex and HIV.

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