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CEL-SCI Hires Clinical Research Organization for Clinical Study With Hospitalized H1N1-Infected Patients
Date:9/23/2009

's concurrence, CEL-SCI anticipates engaging in a detailed dialogue with FDA regarding the proposed LEAPS-H1N1 clinical-development program based upon this future filing.

"Recognizing that this virus was first identified only five months ago, we are moving as fast as possible to investigate the potential of LEAPS-H1N1 to help H1N1-infected patients who are at high risk of dying. We appreciate the expedited review by the FDA of our initial submission, particularly given how much time and attention the expert scientists at FDA are directing to Pandemic Flu amidst all the other demands placed on the Agency in the course of fulfilling its critical public health mission," commented CEL-SCI CEO Geert Kersten.

The initiation of CEL-SCI's rapidly-accelerated LEAPS-H1N1 clinical development program builds on CEL-SCI's pioneering work with its LEAPS technology in the context of H1N1. CEL-SCI's L.E.A.P.S.(TM) (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.

L.E.A.P.S. technology is a novel T-cell modulation platform technology that enables CEL-SCI to design and synthesize, non-recombinantly, proprietary immunogens. 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 the H1N1 hemagglutinin molecule, to make an investigational product that induces defined immune responses. Each L.E.A.P.S. c
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