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.
Copyright Business Wire 2014