VIENNA, Va. and NEW ORLEANS -- Scientists
from the laboratory of Dr. Noel Rose in The Johns Hopkins University
Department of Pathology and CEL-SCI CORPORATION (Amex: CVM) today presented at
the Experimental Biology 2002 meeting, data that could lead to development of
a treatment for autoimmune myocarditis, a life threatening heart disease,
characterized by an enlarged heart. This data showed that the symptoms of
autoimmune myocarditis in a mouse model can be significantly reduced by
immunization with a compound developed by CEL-SCI. These findings may lead to
the preparation of a therapeutic vaccine, which could reduce the severity
and/or prevent progression of autoimmune myocarditis. Myocarditis is a
precursor to dilated cardiomyopathy, a condition leading to a form of chronic
heart failure (CHF) characterized by an inflamed heart. At the end stage of
CHF, a heart transplant is required or death ensues. The incidence in the
United States alone of dilated cardiomyopathy is about 200,000 people.
Dr. Rose's team evaluated administration of a peptide construct
incorporating CEL-SCI's patented technology, L.E.A.P.S. (Ligand Epitope
Antigen Presentation System), in the well-established A/J mouse model of
Experimental Autoimmune Myocarditis. The L.E.A.P.S. construct treated mice
showed significant amelioration of disease symptoms and a marked,
statistically significant decrease in the average disease severity scores from
>2 (5 being maximal severity) in untreated animals to 0.78 (p=0.01) in animals
treated with the construct prior to disease induction. In addition, the
cytokine profile induced by immunization with the L.E.A.P.S. construct changed
to a Th1 (cellular) type from the Th2 (humoral) type normally found in animals
with the autoimmune myocarditis condition.
The most well known autoimmune diseases are rheumatoid arthritis, lupus,
multiple sclerosis and Graves Disease. A common thread among these diseases
is an immune response that "perceives" the persons' own body, cells and organs
as foreign. This in turn, results in relentless attacks by the person's own
immune system against his/her own body, eventually leading to debilitating
sickness, and occasionally to death. If the L.E.A.P.S. is shown to reduce
disease in the animal model for myocarditis, when administered after disease
induction, additional studies will be conducted in animals to test this novel
approach for the treatment of other autoimmune diseases.
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 .
This work was supported in part by a grant from the state of Maryland
Industrial Partnership (MIPS) program.
CEL-SCI Corporation is developing new immune system based treatments for
cancer and infectious diseases. Its lead product, Multikine(TM), is in Phase
II clinical studies against head & neck cancer and Phase I clinical studies
for HIV-infected women with cervical dysplasia. 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 for the year ended September 30, 2001. 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.