CEL-SCI Presents Data Showing LEAPS Vaccine is Successful in Reducing Rheumatoid Arthritis Index Score in a Second Animal Model
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.
