CEL-SCI COLLABORATORS PRESENT DATA SUGGESTING THAT LEAPS TECHNOLOGY HAS ABILITY TO MODIFY IMMUNE RESPONSE
STUDIES SUPPORTIVE OF ROLE THAT TECHNOLOGY CAN PLAY IN TREATMENT OF H1N1 HOSPITALIZED PATIENTS
Vienna, VA, November 9, 2009 – CEL-SCI Corporation (NYSE Amex: CVM) announced today that Dr. Kenneth S. Rosenthal, Professor of Immunology and Microbiology of Northeastern Ohio Universities College of Medicine and Pharmacy, reported on work conducted in collaboration with scientists at the Cleveland Clinic and CEL-SCI on CEL-SCI’s LEAPS vaccine technology. The data was presented at the 7th GTCbio Vaccine: “All Things Considered” Conference in Crystal City, Virginia.
Working with LEAPS vaccines for herpes simplex virus, HIV, rheumatoid arthritis and most recently, H1N1 influenza, the scientists’ studies show that LEAPS peptide immunogens can convert precursor cells from mouse or humans to become dendritic cells (DC), the cell that directs the subsequent immune response. These DCs produce interleukin 12 (IL12p70), but without production of the pro-inflammatory cytokines that promote symptoms of a cytokine storm, such as tumor necrosis factor alpha or interleukin 1. Immunization with a LEAPS-immunogen for herpes simplex virus activates a protective T cell immune response against the virus in mice while a LEAPS-immunogen for treatment of rheumatoid arthritis (CEL-2000) reduces the production of the pro-inflammatory cytokines to block the progression of disease in mouse models of rheumatoid arthritis.
Dr. Rosenthal commented, “LEAPS immunogens are unique in their ability to simultaneously produce and activate a specific type of dendritic cell that can turn on or modulate antigen specific T cell responses without generating the pro-inflammatory cytokines associated with cytokine storm. The ability to activate the desired immune response should make LEAPS immunogens inherently safe vaccines. Finding of similar results for mouse and human cells in our laboratory studies adds confidence that the effects in the body will be the same in mice and man.”
Geert Kersten, CEO of CEL-SCI Corporation said: “We feel that this new data is encouraging and supportive of our H1N1 treatment for hospitalized patients where the goal is to produce a specific anti H1N1 immune response that will steer the immune system towards protection and away from a cytokine storm which may be responsible for many patients’ deaths.”
CEL-SCI’s L.E.A.P.S™ (Ligand Epitope Antigen Presentation System) technology allows the Company to direct an immune response against specific disease epitopes. In the case of CEL-SCI’s investigational LEAPS-H1N1 treatment, this involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu. This is intended to enable stimulation of the specifically-needed immune responses, while avoiding the administration of regions of H1N1, and other viruses, which may exacerbate the problem of cytokine storm, which CEL-SCI scientists believe may be involved in the death of some H1N1 patients.
The concept behind the L.E.A.P.S. technology is to directly mimic cell/cell interactions on the T-cell surface with synthetic peptides. The L.E.A.P.S. constructs containing the antigenic disease epitope linked to a 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]). Therefore, it would appear that the L.E.A.P.S. construct represents a chimeric peptide with bi-functional behavior.
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 in advanced primary head and neck cancer. CEL-SCI is also developing a treatment for hospitalized H1N1 patients using it’s L.E.A.P.S. technology platform, and expects to soon finish the validation of it’s state-of-the-art manufacturing facility in Maryland.
For more information, please visit www.cel-sci.com
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, lack of regulatory clearance to proceed with clinical trials, an inability to duplicate the clinical results demonstrated in clinical studies that have been completed or that are initiated in the future, timely development of any potential products that can be shown to be safe and effective, unwillingness of regulatory authorities to engage in further regulatory dialogue, 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.