|CVM - .735/.736 This is getting some attention today.|
02/22 08:45 CST
CEL-SCI Study Shows CEL-2000 Vaccine Blocks Progression of Rheumatoid
ArthritisStatistically Significant Findings Published in Prestigious Journal of
International ImmunopharmacologyPR Newswire
VIENNA, Va., Feb. 22
VIENNA, Va., Feb. 22 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE AMEX:
CVM)and their scientific collaborators announced today that the Company's
CEL-2000 vaccine demonstrated that it is able to block the progression of
rheumatoid arthritis (RA) in a mouse model. The results were published in the
scientific peer-reviewed Journal of International Immunopharmacology (online
edition) in an article titled "CEL-2000: A Therapeutic Vaccine for Rheumatoid
Arthritis Arrests Disease Development and Alters Serum Cytokine / Chemokine
Patterns in the Bovine Collagen Type II Induced Arthritis in the DBA Mouse
Model" with lead author Dr. Daniel Zimmerman. The study was co-authored by
scientists from CEL-SCI, Washington Biotech, Northeastern Ohio Universities
Colleges of Medicine and Pharmacy (NEOUCOMP) and Boulder BioPath.
CEL-2000, administered after disease (RA) symptoms had started, prevented,
in a statistically significant manner, the further development of arthritic
conditions, including joint swelling and deformation, bone and cartilage
changes and was accompanied by serum cytokine alterations over the CEL-2000
treatment period with comparable or better activity than the well accepted
etanercept (Enbrel) therapy. The mode of action is very consistent with the
findings of induction of IL-12 followed by interferon gamma and an inhibition
of TNF-alpha and IL-17 production. TNF-alpha and IL-17 are both key cytokines
for induction of the pathology seen in rheumatoid arthritis and TNF-alpha is
the target of many current RA therapies such as Enbrel, Remicaid, and Humaria.
The protection effect mediated by CEL-2000 treatment against RA was also
demonstrated histologically with significant reductions in: 1) inflammation, 2)
cartilage destruction, 3) bone resorption, and 4) pannus membrane formation in
the synovial space compared to untreated controls.
Geert Kersten, Chief Executive Officer of CEL-SCI said, "These experimental
results were achieved through a reduction of the inflammatory response that is
known to attack the patients' joints. The mode of action of CEL-2000 in RA
appears to be similar to our new investigational therapy for H1N1 hospitalized
patients, as it attempts to avoid the excess TNF-alpha and other
pro-inflammatory cytokines. We feel that this new data is encouraging both for
this rheumatoid arthritis vaccine as well as in support of our H1N1 treatment
currently under development."
In these studies, mice were injected with collagen to induce the autoimmune
(RA) disease. Therapy with Enbrel or CEL-2000 was initiated after disease (RA)
symptoms have been established and treatment continued for 28 days after the
initiation of a significant, uniform, and measurable level of arthritic disease
in groups of mice. CEL-2000 was administered only twice, however Enbrel had to
be administered every other day for the 28 day study period (as indicated for
Enbrel use). The extent of disease, as measured by deformation of foot joints
(Arthritic Index (AI) score), of untreated animals and any improvements
resulting from CEL-2000 and Enbrel treated animal were then compared. In
another study, CEL-2000 was administered 5 times over a 70 day period and the
animals were monitored for a total study period of 90 days. In each case,
CEL-2000 treatment proved effective in blocking progression of disease (RA)
with statistically significant reduction in AI score compared to controls. The
CEL-2000 treatment was deemed safe and well tolerated without any reported
adverse effects related to treatment.
The CEL-2000 treatment appeared to change the course of the immune response
in the diseased (RA) animals, limiting the development of the destructive
action of Th17 and tumor necrosis factor alpha (TNF-alpha). Analysis of serum
levels of 21 cytokines/chemokines after 10 days of CEL-2000 treatment indicated
reductions in the characteristic cytokine markers of rheumatoid arthritis,
TNF-alpha and IL-17, as well as IL-6, and MCP-1. A number of cytokine changes
were also seen with Enbrel treatment, but to a lesser degree than that seen
with CEL-2000 treatment.
CEL-2000 may also offer a number of potential advantages over existing
rheumatoid arthritis treatments, such as Enbrel. Data collected in the animal
studies conducted with CEL-2000 demonstrated that CEL-2000 is an effective
treatment against rheumatoid arthritis even with administration of many fewer
treatments than for example Enbrel. CEL-2000 is also potentially a more
disease-type specific therapy, should be significantly less expensive to
manufacture, and finally, CEL-2000 could also be useful for patients who are
not able to take or who may be unresponsive to other existing anti-arthritis
This research featured the multidisciplinary team of collaborators bringing
to the project expertise of several different animal models of arthritis
(Washington Biotech), long time association with modern molecular therapies and
evaluation for RA (Bolder Biopath), experience with other LEAPS immunogens, and
experience and expertise studying cytokines and with mechanistic studies of the
LEAPS technology (NEOUCOMP), and peptide technologies (21st Century
Biochemicals) to complement the expertise of the CEL-SCI researchers.
Rheumatoid arthritis treatments comprise an approximately $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 specific against 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. (Ligand Epitope Antigen Presentation System) technology. L.E.A.P.S.
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. technology.
The concept behind the L.E.A.P.S. technology is to directly mimic cell-cell
interactions and activate immune cells with synthetic peptides. The L.E.A.P.S.
constructs containing the antigenic disease epitope linked to a immune-cell
binding ligand (ICBL) can be manufactured by peptide synthesis or by covalently
linking the two peptides. Depending upon the type of L.E.A.P.S. construct and
ICBL 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.
construct represents a chimeric peptide with bi-functional behavior.
Additional details including the full publication with color
photomicrographs of tissue sections, tables and figures are available at
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its
lead product Multikine is being readied for a global Phase III trial in
advanced primary head and neck cancer. CEL-SCI is also developing an
immunotherapy (LEAPS-H1N1-DC) to treat H1N1 hospitalized patients and a vaccine
(CEL-2000) for Rheumatoid Arthritis using its L.E.A.P.S. technology platform.
The LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu,
Avian Flu (H5N1), and the Spanish Flu as CEL-SCI scientists are very concerned
about the creation of a new more virulent hybrid virus through the combination
of H1N1 and Avian Flu, or maybe Spanish Flu. This investigational treatment is
currently being tested in a clinical study at Johns Hopkins University. 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 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, lack of regulatory
clearance to proceed with clinical trials, an inability to duplicate the
clinical results demonstrated in clinical studies that have been completed or
that are initiated in the future, timely development of any potential products
that can be shown to be safe and effective, unwillingness of regulatory
authorities to engage in further regulatory dialogue, 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, 2009. 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