CEL-SCI Study Shows CEL-2000 Vaccine Blocks Progression of Rheumatoid Arthritis
Statistically Significant Findings Published in Prestigious Journal of International Immunopharmacology
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 therapies.
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.(TM) (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 http://dx.doi.org/10.1016/j.intimp.2009.12.016.
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
CONTACT: Gavin de Windt of CEL-SCI Corporation,
+1-703-506-9460
Web Site: http://www.cel-sci.com/
Posted: February 2010
