CEL-SCI Receives $225,000 NIH Research Grant to Develop Rheumatoid Arthritis Treatment
July 15 2014 - 8:00AM
Business Wire
Pre-clinical studies show CEL-SCI’s LEAPS
technology prevented the development and lessened the severity of
rheumatoid arthritis
CEL-SCI Corporation (NYSE MKT: CVM)
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.
When used in this release, 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.
CEL-SCI CorporationGavin de Windt, 703-506-9460
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