CEL-SCI Corporation has been awarded a Phase I SBIR (Small Business Innovation Research) grant from the National Heart, Lung and Blood Institute, National Institutes of Health (NIH), in the amount of $134,000 for the further development of a potential treatment for "autoimmune myocarditis," a heart disease. The work will be done in conjunction with scientists at the laboratory of Noel Rose, Professor of Pathology and Medicine at the Department of Pathology, The Johns Hopkins Medical Institutions, Baltimore, Maryland.
Autoimmune myocarditis, an autoimmune disease affecting the heart muscle, is caused by an attack on the patient's heart muscle by his/her own immune cells and antibodies. Myocarditis is a precursor to dilated cardiomyopathy, which is an end-stage cardiac disease usually requiring a heart transplant. The incidence of dilated cardiomyopathy is about 200,000 people per year in the United States alone. The current treatments are not curative. The ultimate goal of this new research is to create a therapeutic vaccine that will reduce the severity and/or prevent progression of autoimmune myocarditis to cardiomyopathy.
The NIH grant was awarded based on preliminary data presented by Dr. Rose's team in collaboration with CEL-SCI researchers in 2002 showing that administration of a proprietary peptide based on CEL-SCI's L.E.A.P.S. technology has prevented the development, and lessened the severity, including inflammation, of experimental autoimmune myocarditis in mice. The grant will continue these initial therapeutic studies in a well-established mouse model of Experimental Autoimmune Myocarditis.
Dr. Zimmerman, Senior Vice President of Research and Development, Cellular Immunology at CEL-SCI and the inventor of the L.E.A.P.S. technology said, "The successful conclusion of this round of tests in an autoimmune disease could open up the development and application of the L.E.A.P.S. technology to various other autoimmune diseases, such as rheumatoid arthritis, multiple sclerosis and certain types of diabetes."
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. 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.