VIENNA, Va., Feb. 28 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION has been issued a U.S. patent covering its L.E.A.P.S.(TM) peptide vaccine technology in the areas of autoimmunity and allergies. The new patent, U.S. Patent No. 6,995,237, is titled, “Preparation and composition of peptides useful for treatment of autoimmune and transplant related graft versus host conditions.” The L.E.A.P.S. technology has also produced the patented CEL-1000 drug which induced protection in animals against viruses and parasites and is being tested by the National Institute of Allergy and Infectious Diseases against the avian flu virus.
This new patent builds on work by CEL-SCI scientists in collaboration with scientists from the laboratory of Dr. Noel Rose at The Johns Hopkins University Department of Pathology, showing that pretreatment and early therapy of Experimental Autoimmune Myocarditis with a compound developed by CEL-SCI resulted in significant reduction in heart enlargement and disease associated histopathological changes in mice. The compound used was derived from CEL-SCI’s patented L.E.A.P.S. (Ligand Epitope Antigen Presentation System) platform technology.
These findings could potentially lead to the development of a treatment for autoimmune myocarditis, a life threatening heart disease, which is characterized by an enlarged and weakened heart. Myocarditis is a precursor to dilated cardiomyopathy, a condition leading to a form of chronic heart failure (CHF) characterized by an inflamed heart. End stage CHF requires a heart transplant or death ensues. The incidence in the United States alone of dilated cardiomyopathy is about 200,000 people.
The protection against experimentally induced myocarditis was statistically significant for both pretreatment and early therapy with the L.E.A.P.S compound. The response was antigen-specific and was associated with an increase in IL-13 in both the sera and heart tissue and of IL-1 alpha in the sera of the protected mice. Other studies from Dr. Rose’s laboratory with IL-13 knockout-mice (mice missing the IL-13 gene) demonstrated the importance of IL-13 in this animal model of Experimental Autoimmune Myocarditis.
Dr. Daniel H. Zimmerman, Senior Vice President Research, Cellular Immunology, at CEL-SCI said, “These studies showed that we are able to treat mice with ongoing heart disease. This may lead to treatment of autoimmune myocarditis in humans where the disease process is similar to the animal model being studied and reported here. The issuance of a U.S. patent protecting our novel work is very critical to our effort.”
The most well known and common autoimmune diseases are insulin dependent diabetes mellitus, rheumatoid arthritis, lupus, multiple sclerosis, inflammatory bowel and Graves Disease. A common thread among these diseases is an immune response that “perceives” the person’s 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 disease, and occasionally to death. Likewise, the rejection in transplant condition is an immunologically based reaction. In immune mediated allergic reactions the L.E.A.P.S. vaccine is intended to redirect the immune response away from the harmful response in humans to a more subdued response that is not harmful. Current therapies for these conditions generally treat the symptoms of the disease but not the underlying cause of the disease as is done with the L.E.A.P.S. vaccine.
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.
The myocarditis work was supported in part by grants HL071352-01A1, HL67290, HL70729, AI51835 and HL077611 from National Heart, Lung and Blood Institute (NHLBI) and National Institute of Allergy and Infectious Diseases, Institutes of the National Institutes of Health (NIH).
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. The Company’s lead product Multikine(R) is cleared to enter Phase III clinical trials with advanced primary head and neck cancer patients. Other products, in the pre-clinical stage and funded with U.S. government support, have induced protection against a number of diseases in animal tests and are being tested against diseases associated with bio- defense and avian flu.
CEL-SCI Corporation
CONTACT: Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460; orInvestor Relations: Michael Lucci, Jr. of the Lucci Financial Group, LLC,+1-248-723-3330, for CEL-SCI Corporation
Web site: http://www.cel-sci.com/
