Rheumatoid Arthritis Vaccine Reprograms Faulty Immune Responses to Stop/Reduce Attack upon the Joints VIENNA, Va., June 17
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.
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SOURCE CEL-SCI Corporation
