Rheumatoid Arthritis Vaccine Reprograms Faulty Immune Responses to
Stop/Reduce Attack upon the Joints
VIENNA, Va., June 17 /PRNewswire-FirstCall/ -- CEL-SCI Corporation
(Amex: CVM) today announced the discovery of a novel peptide for the
treatment of rheumatoid arthritis. This peptide, called CEL-2000, was
tested in a well established animal model of rheumatoid arthritis and was
compared to Enbrel(R), a leading treatment for people with rheumatoid
arthritis. The tests showed that CEL-2000 is equivalent or possibly
superior to Enbrel in slowing disease progression and lessening symptoms in
mice. In addition, the vaccine has the potential to require fewer and
smaller doses, be less toxic, more disease specific and much less invasive.
The Company also believes that the drug could be attractive to patients who
are not able to take or be responsive to Enbrel, Remicade(R) or Humira(R).
Rheumatoid arthritis treatments comprise a $13 billion market. Enbrel,
a leading rheumatoid arthritis treatment, reported US sales in 2007 of
about $3.2 billion. 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.
Dr. Daniel Zimmerman, Senior Vice President of Research, Cellular
Immunology of CEL-SCI said, "Rheumatoid arthritis is a disease in which the
immune system mistakenly attacks the joints and causes a chronic
inflammation of the joints, leading to a sequel that can result in severe
joint deformation, often with multiple joints involved, and progressive
debilitation. We believe that our CEL-2000 vaccine works by reprogramming
the faulty immune responses that attack the patient's joints to reduce or
stop those attacks."
Dr. Zimmerman continued, "The treatment of rheumatoid arthritis has
undergone many significant improvements in the last 10 years. We hope to
add to those improvements by bringing to market this very easy to
administer and completely novel way of treating patients. Many patients
could benefit from having such a treatment added to their current therapy
or given in place of the current therapy to avoid toxicities." Dr.
Zimmerman presented these new data today at the SMi 4th Biannual Vaccine
Conference in London.
To induce the disease, mice were injected with collagen on days 0 and
21. Once the mice reached a significant and uniform disease state, therapy
with Enbrel and CEL-2000 was initiated. CEL-2000 was administered only
twice and Enbrel was administered every other day over the entire study
period of 28 days.
The mice were scored at least 3 times a week for arthritis index, foot
pad swelling and weekly weight change. Periodically, sera were collected
for assessment of parameters relating to immune status. No significant
weight changes were observed.
Mice administered two doses of CEL-2000, given on either day 0 and 7 or
day 0 and 14, showed a statistically significant decrease in disease
progression and were less symptomatic than the mice given Enbrel every
other day until day 28. Expected serological changes were observed for both
anti-L.E.A.P.S.(TM) vaccines and collagen in these groups.
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 RA. These
therapies remove or inactivate TNF-alpha, a natural human cytokine required
in many immune functions for normal defenses.
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.
Available Topic Expert(s): For information on the listed expert(s), click
appropriate link.
Gavin de Windt
https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=58059
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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