DGAP-News: 4SC Publishes Preclinical Data on Vidofludimus (4SC-101) in Peer-Review Journals

DGAP-News: 4SC Publishes Preclinical Data on Vidofludimus (4SC-101) in Peer-Review Journals

ID: 19804

(firmenpresse) - 4SC AG / Miscellaneous

28.04.2010 07:30

Dissemination of a Corporate News, transmitted by
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The issuer / publisher is solely responsible for the content of this announcement.

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- Inhibition of Interleukin-17 in Inflammatory Bowel Disease and
Efficacy in Systemic Lupus Erythematosus Demonstrated -

Planegg-Martinsried, Germany, April 28, 2010 - 4SC AG (Frankfurt, Prime
Standard: VSC), a drug discovery and development company focused on
autoimmune and cancer indications, today announced that two scientific
publications on vidofludimus (4SC-101), 4SC's lead autoimmune
small-molecule drug, have been published in international peer-reviewed
journals. A manuscript entitled '4SC-101, a Novel Immunosuppressive Drug,
Inhibits IL-17 and Attenuates Colitis in Two Murine Models of Inflammatory
Bowel Disease' has been published in Inflammatory Bowel Diseases, whilst a
comprehensive set of pre-clinical data in a systemic lupus erythematosus
(SLE) model has been released in the American Journal of Pathology under
the title '4SC-101, a novel small molecule dihydroorotate dehydrogenase
inhibitor, suppresses systemic lupus erythematosus in MRL-(Fas)lpr mice'.

The publication in Inflammatory Bowel Diseases is the result of a
collaboration with Prof. Leo R. Fitzpatrick, Department of Pharmacology,
Penn State College of Medicine, USA. Vidofludimus was demonstrated to
effectively improve both chronic and acute inflammatory bowel disease in
mice and to significantly inhibit the production of the pro-inflammatory
cytokine Interleukin-17 (IL-17) both in vitro and in vivo. Since IL-17
inhibition is independent from lymphocyte proliferation and other
signalling molecules such as TNF-?, IL-1? and IL-6 are not affected,
vidofludimus is assumed to block IL-17 production by a highly specific




mechanism which will be evaluated further in this collaboration.

In the American Journal of Pathology publication, the results of a
collaboration with Prof. Hans-Joachim Anders, Medizinische
Poliklinik-Innenstadt, University of Munich, Germany, were published. In
this in vitro and in vivo study, vidofludimus was demonstrated to be as
effective as the standard therapy high dose cyclophosphamide (CYC) in
controlling SLE without causing myelosuppression which is frequently seen
with CYC. Vidofludimus was as effective as CYC in depleting spleen
autoreactive T cells, B cells and plasma cells as well as the respective
DNA and RNA serum auto-antibodies. This was associated with a comparable
amelioration of renal, dermal and pulmonary SLE manifestations of
MRL(Fas)lpr mice. However, even the highest dose of vidofludimus had no
effect on bone marrow neutrophil counts which were significantly reduced in
CYC-treated mice.

Dr Bernd Hentsch, Chief Development Officer of 4SC, commented: 'We are very
excited about the progress we have made in our academic collaborations
which we pursue in parallel to our current clinical development program for
vidofludimus in rheumatoid arthritis and inflammatory bowel disease. These
excellent scientific results substantiate the positioning of vidofludimus
as a novel and broadly applicable anti-inflammatory drug which through its
dual mechanism of action inhibits cell proliferation and the cytokine
IL-17.'

References

- Fitzpatrick LR, Deml L, Hofmann C, Small JS, Groeppel M, Hamm S,
Lemstra S, Leban J, Ammendola A. 4SC-101, a novel immunosuppressive
drug, inhibits IL-17 and attenuates colitis in two murine models of
inflammatory bowel disease. Inflammatory Bowel Diseases 2010. Published
electronically on March 22, 2010.

- Onkar P. Kulkarni, Sufyan G. Sayyed, Claudia Kantner, Mi Ryu, Max
Schnurr, Miklós Sárdy, Johann Leban, Ruediger Jankowsky, Aldo
Ammendola, Robert Doblhofer, and Hans-Joachim Anders. 4SC-101, A Novel
Small Molecule Dihydroorotate Dehydrogenase Inhibitor, Suppresses
Systemic Lupus Erythematosus in MRL-(Fas)lpr Mice. American Journal of
Pathology 2010. Publishedelectronically on April 22, 2010.

About Vidofludimus (4SC-101)

Vidofludimus is a novel, orally administered small molecule that aims to
slow the disease progression in autoimmune diseases such as rheumatoid
arthritis, inflammatory bowel disease, systemic lupus erythematosus and
inflammatory skinconditions. Vidofludimus 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. Vidofludimus also inhibits the
expression of IL-17, a pro-inflammatory cytokine that has a pathogenic role
in autoimmune diseases. The combination of two mechanisms of action
provides an innovative therapeutic approach with broad clinical potential
in various autoimmune diseases. Vidofludimus is currently in a Phase IIb
study in rheumatoid arthritis and a Phase IIa study in inflammatory bowel
disease. More information about the clinical development program of
vidofludimus can be found at www.clinicaltrials.gov.

About 4SC

4SC AG (ISIN DE0005753818) is a drug discovery and development company
focused on autoimmune and cancer indications. Vidofludimus (4SC-101), a
small molecule, is currently in a Phase IIb study in rheumatoid arthritis
and a Phase IIa exploratory study in inflammatory bowel disease. The
company's lead oncology compound, resminostat (4SC-201), a pan histone
deacetylase (HDAC) inhibitor, is in Phase II trials in hepatocellular
carcinoma and Hodgkin's lymphoma. Two further oncology compounds, 4SC-203
and 4SC-205, are in Phase I studies. 4SC develops drug candidates until
proof-of-concept in order to generate value creating partnerships with the
pharmaceutical industry in return for advance and milestone payments as
well as royalties.


4SC was founded in 1997, has 91 employees, and is listed on the Prime
Standard of the Frankfurt Stock Exchange since December 2005.


For further information please visit www.4sc.com.

4SC AG
Dr Bernd Hentsch, Chief Development Officer
Yvonne Alexander, IR&PR
Tel.: +49 (0) 89 70 07 63 66

MC Services (Europe)
Raimund Gabriel
Tel.: +49 (0) 89 21 02 28 40

The Trout Group (USA)
Chad Rubin
Tel.: +1 646 378 2947

Legal Note

This document may contain projections 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.


28.04.2010 07:30 Ad hoc announcement, Financial News and Media Release distributed by DGAP. Medienarchiv atwww.dgap-medientreff.deandwww.dgap.de---------------------------------------------------------------------------

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 NewsDGAP News-Service

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