Company's LEAPS vaccine customized to create next-generation Rheumatoid Arthritis therapy
Vienna, VA, July 11, 2014 -- CEL-SCI Corporation (NYSE MKT: CVM), a late-stage oncology company, announced today that Daniel Zimmerman, Ph.D., its Senior Vice President of Research, Cellular Immunology, delivered a scientific presentation at the 12th Vaccines Research & Development: All Things Considered Conference in Boston, Massachusetts held on July 9-11, 2014.
The presentation entitled "The next generation of Rheumatoid Arthritis therapies: What has been learned from therapeutic vaccines for models of Rheumatoid Arthritis. Is IL-17 the real key to new therapies?" discussed the potential role CEL-SCI's LEAPS vaccines might have on the future treatment of Rheumatoid Arthritis. The presentation centered on the theory that using LEAPS vaccines to treat a complex disease like Rheumatoid Arthritis can be beneficial because CEL-SCI's vaccine can be synthesized to stimulate the appropriate immune response to treat the disease based on its immunodominant cytokine phenotype, which can be predetermined before treatment. The ability to customize the LEAPS treatment in this way offers clear benefits, as compared to using one therapeutic approach such as disease-modifying antirheumatic drugs (DMARDs) that are used today but are not universally applicable across all rheumatoid arthritis patients. The Company presented data which showed that LEAPS vaccines act at an earlier point in the progression of Rheumatoid Arthritis than any other therapy and with more specificity.
According to a survey conducted by Decision Resources, rheumatologists believe there is a high unmet need for Rheumatoid Arthritis therapies which induce remission in a greater percentage of Rheumatoid Arthritis patients than currently available agents. The world rheumatoid arthritis drug market will generate revenues of $38.5 billion in 2017, according to Visiongain.
The data presented included results from studies 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 Mickecz, MD, Ph.D. Professor of Orthopedic Surgery & Biochemistry; and Allison Finnegan, Ph.D. Professor of Medicine. The presentation also drew on work published from others in related autoimmune conditions conducted in animal models and human studies that tested various treatments that are approved or still under investigation. These data supported CEL-SCI's theory that vaccine therapies are more disease specific and act upstream, which are considered advantages, compared to current therapies.
"We have now shown and believe that LEAPS therapies that are tailored to either Th1 or Th17 in Rheumatoid Arthritis models should produce better results than therapies currently on the market, and we expect these findings would be similar in other models and human diseases including multiple sclerosis, uveitis and other autoimmune conditions. We believe that this helps explain why other therapies that are for Th1 signature conditions may not work with Th17 based approach and vice versa. As opposed to current therapies available or in development, LEAPS vaccines target the immune response well before the production of the signature cytokines and not after the cytokines have been produced and released in the inflammatory processes of autoimmune diseases. In our effort to better understand the significance of a T-cell signature cytokine phenotype, our analysis of other related publications indicated that either a Th1 or Th17 cytokine profile in four different animal autoimmune models were specifically induced and discussed for only that particular disease model. However the meanings for therapeutic interventions or overall significance in light of each other were not recognized," stated Dr. Zimmerman.
L.E.A.P.S. is a patented, T-cell modulation, peptide epitope delivery technology that enables CEL-SCI to design and synthesize proprietary peptide immunogens. L.E.A.P.S. compounds consist of a small T-cell binding peptide ligand linked with a disease-associated peptide antigen. This platform technology has been shown in several animal models to preferentially direct immune response to a cellular (e.g. T-cell), humoral (antibody) or mixed pathway. It has the potential to be utilized in diseases for which antigenic epitope sequences have already been identified, such as: a number of infectious diseases, some cancers, autoimmune diseases, allergic asthma and allergy, and select CNS diseases (e.g., Alzheimer's).
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.
When used in this report, the words "intends," "believes," "anticipated", "plans" 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, 2013. 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.