DGAP-News: EULAR 2011 - Vidofludimus Superior to Cyclophosphamide and MMF in an Experimental Systemic Lupus Erythematosus Model
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Research Update
EULAR 2011 - Vidofludimus Superior to Cyclophosphamide and MMF in an
Experimental Systemic Lupus Erythematosus Model
27.05.2011 / 07:30
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- Preclinical data presented at EULAR 2011 -
Planegg-Martinsried, Germany - 27 May, 2011 - 4SC AG (Frankfurt, Prime
Standard: VSC), a discovery and development company of targeted small
molecule drugs for autoimmune and cancer diseases, will present
pre-clinical data on vidofludimus - its lead small-molecule drug candidate
against autoimmune diseases - in systemic lupus erythematosus (SLE) at
EULAR 2011, Europe's largest scientific conference on rheumatic diseases,
in London, UK, from May 25-28, 2011.
Vidofludimus is a novel oral inhibitor of dihydroorotate dehydrogenase
(DHODH) and of pro-inflammatory cytokine release including interleukin-17
(IL-17A and IL-17F) as well as interferon-gamma which is in Phase IIb
development for rheumatoid arthritis and has completed a positive Phase IIa
study in inflammatory bowel disease. Additionally, the drug candidate has
been demonstrated to be highly active in pre-clinical models of further
autoimmune diseases such as multiple sclerosis, psoriasis, and transplant
rejection. In collaboration with Prof. Dr. Hans-Joachim Anders,
Medizinische Poliklinik Innenstadt, University Munich, Germany, the
anti-inflammatory and immunosuppressive activity of vidofludimus was
directly compared to cyclophosphamide (CYC) and mycophenolate mofetil (MMF)
in an experimental animal model of SLE (MRLlpr/lpr).
Vidofludimus was as effective as CYC and MMF in inhibiting progression
parameters of renal disease. Furthermore, vidofludimus improved activity
and chronicity indices, markers of renal inflammation. In contrast, CYC and
MMF had no significant effect on these activity indices. Treatment with
vidofludimus also significantly reduced peribronchiolar inflammation, while
CYC and MMF failed to achieve any protection of the lung. Vidofludimus
reduced lympho-proliferation and was equipotent to CYC and superior
compared to MMF. Vidofludimus also was more effective than CYC and MMF in
reducing circulating plasma IL12p40 and tissue auto-antibodies (IgG). In
contrast to CYC and MMF, vidofludimus showed no bone marrow toxicity
effects as measured by monocyte and neutrophil counts.
These data provide evidence that delayed onset of therapy with vidofludimus
is effective in suppressing immunopathology and autoimmune tissue injury of
MRLlpr/lpr mice. This efficacy was comparable to CYC with respect to
suppression of experimental SLE. However, vidofludimus did not cause
myelosuppression like the unselective cell proliferation inhibitor CYC
which may relate to the more specific mode of action of vidofludimus.
Vidofludimus had a superior activity profile than MMF in this mouse model
of SLE. Thus, vidofludimus may represent a novel drug that could control
active SLE like CYC but avoid CYC toxicity and could, therefore, be
considered for induction and maintenance therapy of SLE.
Dr Bernd Hentsch, Chief Development Officer of 4SC, commented: 'In addition
to vidofludimus' primary target indications rheumatoid arthritis and
inflammatory bowel disease, vidofludimus demonstrated the potential to
effectively control active SLE in an experimental preclinical model without
the type of side effects often seen with standard therapies. Therefore,
vidofludimus could be considered to be positioned as a novel induction and
maintenance therapy for lupus, an autoimmune disease with significant unmet
need and poor therapeutic options available.'
Details of the presentation:
SAT0477: 'Vidofludimus shows a superior profile compared to
cyclophosphamide
and MMF in an experimental systemic lupus erythematosus model'
Date and time: 28 May 2011 from 9:00 to 12:00 a.m.
Topic: SLE, Sjögren's and APS - etiology, pathogenesis and animal models
Session type: Poster Session
Presenter: Onkar Kulkarni1, Hans-Joachim Anders1, Robert Doblhofer2,
Bernd
Hentsch2, and Aldo Ammendola2
1Medizinische Poliklinik Innenstadt, University Munich, Germany; 24SC AG,
Planegg-Martinsried, Germany
A copy of the poster presentation is available on the 4SC website under:
http://www.4sc.de/product-pipeline/publications-posters.
Notes to Editor:
About Vidofludimus
Vidofludimus is a novel, orally administered small molecule for the
treatment of autoimmune disorders such as rheumatoid arthritis and
inflammatory bowel disease. The therapeutic efficacy of vidofludimus is
based on a dual principle. Vidofludimus inhibits the expression of selected
pro-inflammatory cytokines, including interleukin-17 (IL-17A and IL-17F)
and interferon-gamma, that have crucial pathogenic roles in a variety of
autoimmune diseases. Vidofludimus also inhibits dihydroorotate
dehydrogenase (DHODH), a key enzyme of the pyrimidine biosynthesis, thereby
halting the proliferation of activated T and B cells which are involved in
the pathology of autoimmune disorders. The combination of two mechanisms of
action provides an innovative therapeutic approach with broad clinical
potential in various autoimmune diseases. Vidofludimus is currently in
clinical development for rheumatoid arthritis and inflammatory bowel
disease.
About Systemic Lupus Erythematosus
Systemic lupus erythematosus, SLE, is a systemic autoimmune disease that
can affect any part of the body. As occurs in other autoimmune diseases,
the immune system attacks the body's cells and tissue, resulting in
inflammation and tissue damage. It is a Type III hypersensitivity reaction
caused by antibody-immune complex formation. SLE most often harms the
heart, joints, skin, lungs, blood vessels, liver, kidneys, and nervous
system. The course of the disease is unpredictable, with periods of illness
(flares) alternating with remissions. The disease occurs nine times more
often in women than in men, especially in women of child-bearing potential,
i.e. between 15 to 35 years of age, and is also more common in those of
non-European descent. Although SLE is treatable through addressing its
symptoms mainly with cyclophosphamide, corticosteroids and
immunosuppressants, there is currently no cure. SLE can be fatal, although
with recent medical advances, fatalities are becoming increasingly rare.
Survival for people with SLE in the United States, Canada, and Europe is
approximately 95% at five years, 90% at 10 years, and 78% at 20 years. With
belimumab (benlysta), an i.v. antibody, the first novel therapy after about
50 years has been recently approved.
About 4SC
4SC (ISIN DE0005753818) discovers and develops targeted, small-molecule
drugs for the treatment of diseases with a high unmet medical need in
various autoimmune and cancer indications. These drugs are intended to
provide patients with innovative treatment options that are more tolerable
and efficacious than existing therapies, and provide a better quality of
life. The company's balanced pipeline comprises promising products that are
in various stages of clinical development. 4SC's aim is to generate future
growth and enhance its enterprise value by entering into partnerships with
leading pharmaceutical companies.
Founded in 1997, 4SC currently has 94 employees and has been listed on the
Prime Standard of the Frankfurt Stock Exchange since December 2005.
For further information, please visit www.4sc.com.
Legal Note
This document may containprojections or estimates relating to plans and
objectives relating to our future operations, products, or services; future
financial results; or assumptions underlying or relating to any such
statements; each of which constitutes a forward-looking statement subject
to risks and uncertainties, many of which are beyond our control. Actual
results could differ materially, depending on a number of factors.
For more information please contact:
4SC AG
Yvonne Alexander, IR&PR
Tel.: +49 (0) 89 70 07 63 66
MC Services (Europe)
Raimund Gabriel
Tel.: +49 (0) 89 21 02 28 30
The Trout Group (USA)
Chad Rubin
Tel.: +1 646 378 2947
End of Corporate News
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Language: English
Company: 4SC AG
Am Klopferspitz 19a
82152 Martinsried
Deutschland
Phone: +49 (0)89 7007 63-0
Fax: +49 (0)89 7007 63-29
E-mail: public(at)4sc.com
Internet: www.4sc.de
ISIN: DE0005753818
WKN: 575381
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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126386 27.05.2011
Datum: 27.05.2011 - 07:30 Uhr
Sprache: Deutsch
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