Sexual HealthCEL-SCI Developing Immune-Based Treatment Against Swine And Other H1N1 Flu Viruses Using Proprietary L.E.A.P.S. Technology
CEL-SCI Corporation (NYSE AMEX: CVM) announced that it is developing an immune-based treatment for the "swine flu and related H1N1" flu viruses, utilizing its proprietary L.E.A.P.S.(TM) (Ligand Epitope Antigen Presentation System) vaccine technology. The Company plans to utilize the expertise and knowledge it has gained from developing protective and therapeutic vaccines utilizing L.E.A.P.S. to develop a therapeutic treatment based upon the technology for people infected with the swine and H1N1 flu viruses. CEL-SCI has already commenced pre-clinical testing.
Previously, CEL-SCI announced that its CEL-1000 peptide, which is derived from the L.E.A.P.S. technology, showed adjuvant activity when used with a peptide based malaria vaccine and a DNA based malaria vaccine in animal challenge studies as part of a Cooperative Research arrangement with the Naval Medical Research Center, Silver Spring, MD. In both cases, the addition of CEL-1000 to the vaccines resulted in significant increases in the protection of the animals. In addition, several different L.E.A.P.S. conjugates induced protection and/or improvement in diseases as diverse as rheumatoid arthritis, malaria, TB and herpes simplex viruses. This shows that the L.E.A.P.S. technology can be successfully applied to many different diseases and these results further suggest that L.E.A.P.S. has the potential to be used either alone as a therapy or as an adjuvant to vaccines under development for the treatment of H1N1 related flu viruses. Adjuvants are designed to improve the effectiveness of vaccines.
"We believe that our L.E.A.P.S. technology platform offers strong potential to address the current swine and H1N1 flu viruses," said Dr. Daniel Zimmerman of CEL-SCI, the inventor of the technology. "With the swine flu currently creating major global health problems despite it occurring outside of the traditional windows for the flu, we are working diligently to provide a solution as it is expected that the disease may become even more virulent later this year during the traditional flu season."
The reason why the L.E.A.P.S. technology lends itself to creating a much more effective immune therapy against the H1N1 flu virus is because the L.E.A.P.S. conjugates induce an effective and powerful immune response without causing excessive amounts of pro-inflammatory cytokines. In the case of prior pandemic influenza, such as the "Spanish Influenza" and more recently the "Avian Flu", patients with stronger immune systems had a greater chance of dying because their immune response was too strong (too many pro-inflammatory cytokines). This is called a cytokine storm. While normally many cytokines play a key role in preventing and treating swine flu, in some cases excessive cytokine amounts may exacerbate the disease as it appears that, unlike the normal flu which affects the very young and very old most severely, swine flu may be more like the avian flu which hits people in their prime more severely.
In addition, LEAPS conjugates may be used to potentially overcome the virus" mutations by focusing on more conserved and common epitopes critical for critical viral function.
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 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.
CEL-SCI Corporation