AEGiS-PRn: CEL-SCI Corporation Announces Publication of Promising Preclinical Results

Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.

CEL-SCI Corporation Announces Publication of Promising Preclinical Results

PRNewswire - December 5, 2001

VIENNA, Va., Dec. 5 /PRNewswire/ -- CEL-SCI CORPORATION (Amex: CVM) announces the peer-reviewed publication of important work in VACCINE (19(32) 4750-9). In the article, the researchers demonstrated that animals given CEL-SCI's experimental L.E.A.P.S. based HIV vaccine agent, showed strong evidence supporting the induction of cellular immune responses and antibodies, both of which recognize different strains of the HIV virus. Potentially even more important to the field of vaccine research is the finding that, even after repeat administration, only minimal immune responses were developed against the delivery peptides used by the L.E.A.P.S. technology (called a T-cell Binding Ligand), while strong immune responses were elicited against the HIV portion of the peptide. This may indicate that, unlike other epitope delivery technologies currently being developed, the immune response induced by these L.E.A.P.S. constructs is focused on the disease epitope, as opposed to the "carrier" or "delivery" parts, and that such constructs are more likely to be suitable for long term administration in infected patients.

Daniel Zimmerman, Senior Vice President Research, Cellular Immunology of CEL-SCI, and inventor of the technology said, "Treatment vaccines are thought to represent a whole new way of treating patients in the future. The problem with the required repeat administration of the vaccines often is that the body will develop a strong immune response against parts of the vaccine that are only needed for the presentation of the vaccine to the immune system. This is undesirable for the patients' health. Our L.E.A.P.S. technology may remove that obstacle."

Other delivery technologies for peptide epitopes, such as KLH, Heat Shock Proteins (HSP), VP22 (Herpes simplex virus protein 22kDa), AutoVac(TM), LEif(TM), recombinant viral vectors and Virus Like Particles (VLP), have the major disadvantage of using large, very immunogenic molecules.

Immunotherapeutic agents utilizing these technologies may at best be administered a limited number of times without adverse immune system consequences. Because patients frequently have been exposed to many of these antigens, clearance by the immune system of the vector can be so rapid as to minimize the response elicited against the new antigen. In conclusion, the lack of immune responses against the T-cell Binding Ligand used by the L.E.A.P.S. technology indicates that L.E.A.P.S. conjugates are likely to be better immunotherapeutic agents for the treatment of diseases, such as HIV, because they are more suitable for long term administration.

L.E.A.P.S. is currently being evaluated in eight announced collaborations: National Cancer Institute (both cancer and HIV), Max-Delbruck Center for Molecular Medicine, Berlin (cancer), Johns Hopkins University (heart disease), University of Maryland (TB), University of Nebraska Medical Center (HIV), U.S. Naval Medical Research Center (malaria), and Northeastern Ohio Universities College of Medicine (herpes simplex). Most of this work is being done with government grants and Cooperative Research agreements.

L.E.A.P.S. is a novel T-cell modulation platform technology that enables CEL-SCI to design and synthesize proprietary immunogens. L.E.A.P.S. compounds ("constructs") consist of a peptide epitope associated with a disease-causing agent linked to a T-cell binding peptide ligand (TCBL). Together they induce the immune system to mount either a cellular (e.g., T-cell), humoral (antibody) or a mixed immune response as a means to treat, control or prevent disease. Therefore, L.E.A.P.S. is thought to be a delivery vehicle that directs or controls the immune response to the desired outcome. This ability to preferentially direct the immune system is a major breakthrough. Any diseases for which antigenic epitope sequences have been identified, such as infectious diseases, cancer, autoimmune diseases, allergic asthma and allergy, are potential candidates for this technology. More information on L.E.A.P.S. is available at http://www.cel-sci.com .

CEL-SCI Corporation is developing new immune system based treatments for cancer and infectious diseases. The Company has operations in Vienna, Virginia and Baltimore, Maryland.

"CEL-SCI press releases are available through Company News On-Call at http://www.PRNewswire.com , or at http://www.cel-sci.com on the Internet."

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 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 for the year ended September 30, 2000.

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 Web Site: http://www.cel-sci.com

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