CEL-SCI Announces $1.5 Million NIH SBIR Grant to Support Development of Rheumatoid Arthritis Vaccine
September 19 2017 - 9:00AM
Business Wire
Previous pre-clinical studies show CEL-SCI’s LEAPS technology
prevented the development, lessened the severity of arthritis and
described in part the mechanism of action and target cells
CEL-SCI Corporation (NYSE American: CVM)
announced today that it has been awarded a new Phase II Small
Business Innovation Research (SBIR) grant by the National Institute
of Arthritis and Musculoskeletal and Skin Diseases entitled
“Preclinical studies of PG70 LEAPS peptide vaccine for rheumatoid
arthritis”. The grant in the amount of approximately $1.5 million
will provide funding to allow CEL-SCI to advance its first LEAPS
product candidate, CEL-4000, towards an Investigational New Drug
(IND) application, by funding GMP manufacturing, IND enabling
studies, and additional mechanism of action studies.
The work will be conducted at CEL-SCI’s research laboratory and
Rush University Medical Center in Chicago, Illinois at the
laboratories of Tibor Glant, MD, Ph.D., The Jorge O. Galante
Professor of Orthopedic Surgery and Katalin Mikecz, MD, Ph.D.
Professor of Orthopedic Surgery & Biochemistry.
The grant was awarded based on published 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 proteoglycan induced arthritis (PGIA or GIA) when
it was administered after the disease was induced in the animals.
This data was recently published in Vaccine in an article titled
“An epitope-specific DerG-PG70 LEAPS vaccine modulates T cell
responses and suppresses arthritis progression in two related
murine models of rheumatoid arthritis” by Mikecz et al.
“These findings, in conjunction with the results from previously
conducted studies with LEAPS vaccines in the PGIA and GIA and other
autoimmune models suggest that LEAPS vaccines may be used as a
therapeutic treatment in a variety of different types of autoimmune
conditions. 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 Senior Vice President of Research, Daniel Zimmerman,
Ph.D.
Dr. Zimmerman continued, “The successful conclusion of this
round of studies in this autoimmune disease takes LEAPS closer to
human studies and could open its development to various other
autoimmune diseases, such as multiple sclerosis, uveitis, colitis
(inflammatory bowel disease) and certain types of diabetes.”
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 immunotherapy, Multikine* (Leukocyte Interleukin,
Injection), is currently being studied in a pivotal Phase 3
clinical trial as a potential neoadjuvant treatment for patients
with squamous cell carcinoma of the head and neck. The study was
designed with the objective that, if the study endpoint, which is
an improvement in overall survival of the subjects treated with the
Multikine treatment regimen plus the current standard of care (SOC)
as compared to subjects treated with the current SOC only, is
satisfied, the study results will be used to support applications
that the Company plans to submit to regulatory agencies in order to
seek commercial marketing approvals for Multikine in major markets
around the world. The Company’s LEAPS technology is being developed
as a therapeutic vaccine for rheumatoid arthritis and is supported
by grants from the National Institutes of Health.
The Company has operations in Vienna, Virginia, and in/near
Baltimore, Maryland.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. When used in this press 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 that 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’s filings with the Securities and Exchange Commission,
including but not limited to its report on Form 10-K and 10-K/A for
the year ended September 30, 2016. 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.
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