CEL-SCI Receives $225,000 NIH Research Grant to Develop Rheumatoid Arthritis Treatment

CEL-SCI Corporation

Pre-clinical studies show CEL-SCI’s LEAPS technology prevented the development and lessened the severity of rheumatoid arthritis

July 15, 2014

CEL-SCI Corporation announced today that it has been awarded a Phase I Small Business Innovation Research (SBIR) grant in the amount of $225,000 from the National Institute of Arthritis Muscoskeletal and Skin Diseases (NIAMS), which is part of the National Institutes of Health (NIH). The grant will fund the further development of CEL-SCI’s LEAPS technology as a potential treatment for rheumatoid arthritis (RA), an autoimmune disease of the joints. According to Visiongain, the world rheumatoid arthritis drug market will generate revenues of $38.5 billion in 2017.

The work will be conducted at Rush University Medical Center in Chicago, Illinois in the laboratories of Tibor Glant, MD, Ph.D., The Jorge O. Galante Professor of Orthopedic Surgery; Katalin Mikecz, MD, Ph.D. Professor of Orthopedic Surgery & Biochemistry; and Allison Finnegan, Ph.D. Professor of Medicine.

The NIH grant was awarded based on preliminary data by Dr. Glant’s team in collaboration with CEL-SCI showing that the administration of a proprietary peptide using CEL-SCI’s LEAPS technology prevented the development, and lessened the severity, including inflammation, of experimental RA when it was administered after the disease was induced in the animals. This data was presented in May 2013 by Daniel Zimmerman, Ph.D., CEL-SCI’s Senior Vice President of Research, Cellular Immunology, at the symposium on “Therapeutic Approaches to Autoimmunity” during the American Association of Immunologists (AAI) 100th annual meeting in Honolulu, Hawaii.

“These findings, in conjunction with the results from previously conducted studies with LEAPS vaccines in other RA models suggest that LEAPS vaccines may be used as a therapeutic treatment for different types of RA. 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,” said CEL-SCI’s Dr. Zimmerman.

Dr. Zimmerman continued, “The successful conclusion of this round of studies in this autoimmune disease could take LEAPS closer to human studies and open its development to various other autoimmune diseases, such as multiple sclerosis, uveitis, colitis (Inflammatory Bowel disease) and certain types of diabetes.”

The NIH grant will fund studies in a well-established mouse model for Th1 Proteoglycan induced arthritis (PGIA) as developed by Drs. Glant and Mikecz and recently expanded to a Th17 PGIA by Drs. Finnegan and Glant. These two PGIA models are significant in that they more closely approximate human disease with the concurrent presence of rheumatoid factor and anti citrulline peptide antibodies and spondylitis that are not seen in most arthritis models.

About Rheumatoid Arthritis

Rheumatoid Arthritis 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’s work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational therapy Multikine (Leukocyte Interleukin, Injection) is currently being studied in a pivotal Phase III clinical trial against head and neck cancer. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with Multikine treatment regimen as compared to subjects treated with current standard of care only is satisfied, the study results will be used to support applications which will be submitted to regulatory agencies in order to receive from these agencies commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine which are being investigated include cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase I trial in conjunction with the U.S. Navy under a CRADA (Cooperative Research and Development Agreement).

CEL-SCI is also developing its LEAPS technology for the treatment of pandemic influenza and as a potential therapeutic vaccine against rheumatoid arthritis. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.

For more information, please visit www.cel-sci.com.

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