CEL-SCI Reports Preclinical Data Showing LEAPS Vaccine is Successful in Treating Rheumatoid Arthritis
November 14 2016 - 9:00AM
Business Wire
- Suppresses arthritis severity and
limits joint damage
- Down-regulates pro-inflammatory
T-cell responses
CEL-SCI Corporation (NYSE MKT: CVM), a biotechnology
company dedicated to research and development directed at improving
the treatment of cancer and other diseases by utilizing the immune
system, today announced new preclinical data that demonstrate its
investigational new drug candidate CEL-4000 has the potential for
use as a therapeutic vaccine to treat rheumatoid arthritis.
CEL-4000 has been developed using CEL-SCI’s patented LEAPS (Ligand
Epitope Antigen Presentation System) technology. Data were
presented by Daniel Zimmerman, Ph.D., CEL-SCI’s Senior Vice
President of Research, Cellular Immunology, at the American College
of Rheumatology’s Annual Meeting in Washington DC. The poster
presentation titled, “A Therapeutic Peptide Vaccine Reduces
Pro-inflammatory Responses and Suppresses Arthritis in the
Cartilage Proteoglycan G1 Domain-induced Mouse Model of Rheumatoid
Arthritis,” was presented on November 14, 2016.
This study was supported in part by funding of 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), a part of the National Institutes of Health
(NIH). The study was conducted in collaboration with Drs. Katalin
Mikecz and Tibor Glant, and their research team at Rush University
Medical Center in Chicago, IL.
“These findings, in conjunction with the results from earlier
animal studies with LEAPS vaccines, support the potential that
LEAPS vaccines may be useful as a therapeutic treatment for
different types of rheumatoid arthritis. LEAPS vaccines may be
advantageous to other therapies because they appear to act early on
the immune system and inhibit the production of disease-promoting
inflammatory cytokines. This is a significant step forward in the
development of the LEAPS technology,” said Dr. Zimmerman.
This efficacy study evaluated the LEAPS vaccine’s effect in both
the Proteoglycan (PG) induced arthritis (PGIA) and the closely
related recombinant huG1 domain of PG (GIA) both in animal models
of rheumatoid arthritis (RA) having a dominant T helper 1 (Th1)
cytokine profile. These animal models were developed and have been
studied extensively in Dr. Glant’s laboratory for over 25 years and
are considered to be closely related to the human condition of many
RA patients. The PGIA and GIA model also exhibits rheumatoid factor
(Rf), RA-specific antibodies ACPA (anti citrulline peptide
antibodies) and tend to develop spondylitis not usually seen in
other RA models.
Disease severity, as determined on the basis of the Arthritis
Index and histopathology, was suppressed in mice treated with the
LEAPS vaccine when compared to controls. As initially reported
based on preliminary data in the PGIA model only, the reduction in
disease (RA) severity following LEAPS vaccination with CEL-4000
(DerG-PG70 treatment) correlated with up-regulation of T regulatory
cells (Treg) 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).
About Rheumatoid Arthritis
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. Non-steroidal, as well as steroidal
anti-inflammatory medicines and now more commonly the use of
anti-TNFα related therapies are the current standard treatment of
patients with advanced RA, but information suggests that over half
of the RA patients treated do not respond to current anti-TNFα
drugs such as etanercept (Enbrel®) and infliximab (Remicade®).
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, 2015. 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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