VIENNA, Va., Sept. 5 /PRNewswire-FirstCall/ -- CEL-SCI Corporation
(Amex: CVM) announced today that it presented new rheumatoid arthritis data
at the Marcus Evans conference on Immunogenicity in Amsterdam. The data,
presented by Dr. Daniel Zimmerman, Senior Vice President of Research,
Cellular Immunology of CEL-SCI, indicate that CEL-SCI's rheumatoid
arthritis vaccine CEL-2000 prevents or retards the permanent tissue damage
caused by rheumatoid arthritis in an animal model of the disease. These new
findings further support previous positive results announced for this
vaccine in June 2008. The data were derived from a histopathological
analysis of tissues samples collected in comparative studies of CEL-2000
and Enbrel(R) that were conducted in a well established animal model of
rheumatoid arthritis. Enbrel is a leading treatment for people with
rheumatoid arthritis.
In the studies, the mice were injected with collagen on days 0 and 21
to induce the disease. Once the mice reached a significant and uniform
disease state, therapy with Enbrel or CEL-2000 was initiated and continued
for 28 days. CEL-2000 was administered only twice and Enbrel was
administered either every day for the first 14 days (for the histopathology
and immunology studies) or every other day over the entire study period of
28 days (for the immunology studies only).
Dr. Zimmerman reported previously that in studies conducted in mice
treated similarly, CEL-2000 was equivalent or possibly superior to Enbrel
in slowing disease progression and lessening symptoms. The new data
presented today indicate that, in mice vaccinated with CEL-2000 after
appearance of visible disease, statistically significant less inflammation
and permanent damage with regard to 1) bone erosion, 2) cartilage
destruction, and 3) pannus formation were observed. These are some of the
same parameters that can be seen in rheumatoid arthritis damage in humans.
CEL-2000 was as good as, and possibly superior to, Enbrel in slowing
further disease progression as evaluated by these histological parameters
and by footpad swelling as well as externally visible joint damage.
"It is very exciting to see the reduction of severe rheumatoid
arthritis damage in these animals through a simple vaccination," said Dr.
Zimmerman. "I hope that CEL-2000 will some day be used to lessen the damage
caused by rheumatoid arthritis in patients."
CEL-2000 may offer a number of potential advantages over the existing
rheumatoid arthritis treatments. Data collected in the animal studies
conducted with CEL-2000 demonstrate it is effective with fewer and smaller
doses. It is also potentially less toxic and more disease specific therapy.
Finally, CEL-2000 could also be useful for patients who are not able to
take or who may be unresponsive to existing products.
Rheumatoid arthritis treatments comprise a $13 billion market. Enbrel,
a leading rheumatoid arthritis treatment sold by Amgen and Wyeth, reported
US sales in 2007 of about $3.2 billion. Enbrel is a soluble recombinant
protein of a human TNF-alpha receptor linked to human IgG Fc. In some
cases, human or humanized monoclonal antibodies to TNF-alpha have also been
used for therapy in rheumatoid arthritis. These therapies remove or
inactivate TNF-alpha, a natural human cytokine required in many immune
functions for normal defenses.
CEL-SCI's rheumatoid arthritis vaccine CEL-2000 was discovered as part
of work with the Company's ongoing research and development activities with
its L.E.A.P.S.(TM) (Ligand Epitope Antigen Presentation System) technology.
L.E.A.P.S.(TM) is a novel T-cell modulation platform technology that
enables CEL-SCI to design and synthesize proprietary immunogens. Any
disease for which an antigenic sequence has been identified, such as
infectious, parasitic, malignant or autoimmune diseases and allergies, are
potential therapeutic or preventive sites for the application of
L.E.A.P.S.(TM) technology.
The concept behind the L.E.A.P.S.(TM) technology is to directly mimic
cell/cell interactions on the T-cell surface with synthetic peptides. The
L.E.A.P.S.(TM) constructs containing the antigenic disease epitope linked
to a T-cell binding ligand (TCBL) can be manufactured by peptide synthesis
or by covalently linking the two peptides. Depending upon the type of
L.E.A.P.S.(TM) construct and TCBL used, CEL-SCI is able to direct the
outcome of the immune response towards the development of T-cell function
with primarily effector T-cell functions (T Lymphocyte; helper/effector T
lymphocyte, type 1 or 2 [Th1 or Th2], cytotoxic [Tc] or suppressor [Ts]).
Therefore, it would appear that the L.E.A.P.S.(TM) construct represents a
chimeric peptide with bi-functional behavior.
About CEL-SCI:
CEL-SCI Corporation is developing products that empower immune
defenses. Its lead product is Multikine(R). In Phase II clinical trials,
Multikine was shown to be safe and well tolerated, and to improve the
patients' overall survival by 33% at a median of three and a half years
following surgery. The U.S. Food and Drug Administration (FDA) gave the
go-ahead for a Phase III clinical trial with Multikine in January 2007 and
granted orphan drug status to Multikine in the neoadjuvant therapy of
squamous cell carcinoma (cancer) of the head and neck in May 2007.
The Company has operations in Vienna, Virginia, and Baltimore,
Maryland. CEL-SCI's other products, which are currently in pre-clinical
stage, have shown protection against a number of diseases in animal tests
and are being tested against diseases associated with bio-defense and avian
flu.
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, 2007. 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.
SOURCE CEL-SCI Corporation
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Related links:
http://www.cel-sci.com
CONTACT:
Gavin de Windt of CEL-SCI Corporation,
+1-703-506-9460
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