CEL-SCI Presents Data Showing LEAPS Vaccine is Successful in Reducing Rheumatoid Arthritis Index Score in a Second Animal Model
VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE MKT: CVM) today announced results from a recently completed efficacy study in a second animal model of rheumatoid arthritis (RA) using the LEAPS technology (LEAPS), which demonstrates that LEAPS has the potential for use as a therapeutic vaccine to treat different types of RA, each of which possesses different disease characteristics. The study was conducted in collaboration with Dr. Tibor Glant's research team at Rush University Medical Center. Dr. Glant holds the "Jorge O. Galante, MD" Endowed Chair Professorship in Orthopedic Surgery at Rush. The data was presented on May 4th by Daniel Zimmerman, Ph.D., CEL-SCI's Senior Vice President, Cellular Immunology, at the symposium on "Therapeutic Approaches to Autoimmunity" during the American Association of Immunologists (AAI) 100th annual meeting in Honolulu, HI.
The efficacy study evaluated the LEAPS vaccine's effect in the Proteoglycan induced arthritis (PGIA) model of RA with a dominant T helper 1 (Th1) cytokine profile. The PGIA model was developed and has been studied extensively in Dr. Glant's laboratory at Rush University Medical Center for over 25 years and is considered to be closely related to the human condition of many RA patients. The PGIA model exhibits rheumatoid factor (Rf) and RA-specific antibodies not seen in other RA models.
Disease severity, as determined on the basis of the Arthritis Index and histopathology, was significantly suppressed in mice treated with the LEAPS vaccine when compared to controls. The marked reduction in disease (RA) severity following LEAPS vaccination (treatment) correlated with up-regulation of T regulatory cells and Th2 cytokines (IL-10, IL-4 and TGF-β), reduced proliferation of PG specific T lymphocytes, and decreases in the production of Th1 and Th17 cytokines (IFN-γ and IL-17).
The LEAPS vaccines in this preliminary study consisted of a disease epitope (portion of a disease associated antigen protein) attached to a portion of another very small peptide immune cell binding ligand (ICBL) chosen to promote and direct the immune response away from a Th1 response. When the ICBL and the disease-related Proteoglycan epitope were conjugated to each other, one of the LEAPS vaccines promoted protective immune responses reduced arthritis symptoms in the animals.
"These findings, in conjunction with the results from previously conducted studies with LEAPS vaccines in the RA model of Collagen Induced arthritis (CIA) with a dominant Th17 cytokine profile, suggest that LEAPS vaccines may be used as a therapeutic treatment for different types of RA, which depend on the proteins implicated (e.g., Proteoglycan or Collagen), genetic factors, and different cytokine profiles (e.g., Th1 or Th17). LEAPS vaccines may be advantageous to other therapies because the LEAPS vaccines act early on the immune system and inhibit the production of disease-promoting inflammatory cytokines, unlike anti-Tumor necrosis factor alpha (TNFa) therapy which generally acts late and neutralizes only one individual inflammatory cytokine out of many involved in the disease process. This is a significant step forward in the development of the LEAPS technology in hopes of taking it into human studies," said Dr. Zimmerman.
RA is a chronic inflammatory disease that mainly targets the synovial membrane, cartilage and bone. It affects about 1% of the global population and is associated with significant morbidity and increased mortality. Anti-TNF related therapies are the current standard treatment of patients with advanced RA, but over half of the RA patients do not respond to current anti-TNF drugs such as etanercept (Enbrel®) and infliximab (Remicade®).
About CEL-SCI Corporation
CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned about the possible emergence of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
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, 2012. 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.
Gavin de Windt, 703-506-9460
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