4SC AG — Environmental & Social Information 2009

May 28, 2009

News Details

Corporate | 28 May 2009 08:00

4SC Presents New Pre-clinical Inflammatory Bowel Disease Data on 4SC-101 at Digestive Disease Week

4SC AG / Research Update

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Martinsried/Munich, Germany, May 28, 2009 - The drug discovery and
development company 4SC AG (Frankfurt, Prime Standard: VSC) today announced
that it will present new pre-clinical data on 4SC-101, a small molecule for
the treatment of inflammatory bowel disease (IBD), at the Digestive Disease
Week (DDW) conference in Chicago, USA, from May 30 to June 4, 2009. Jointly
with its collaborator Leo R. Fitzpatrick from the Department of
Pharmacology, Penn State College of Medicine, USA, 4SC will present data on
the efficacy of 4SC-101 in an established pre-clinical model for IBD, which
demonstrated that 4SC-101 significantly improved various disease parameters
and inhibited the colonic expression of pro-inflammatory cytokines IL-17
and Interferon-gamma (IFN-gamma).

Trinitrobenzene sulfonate (TNBS) induced colitis is a well-characterized
animal model for human chronic IBD, in particular Crohn's Disease, in which
the efficacy of 4SC-101 was tested in different dosages. Macroscopic
colonic scores (a combination of lesions, diarrhea, adhesions, and
thickness) and colonic ulcer severity were significantly attenuated in mice
treated with 4SC-101. Colonic histology scores were dramatically reduced (p
< 0.05 vs. Vehicle) in all drug treatment groups. When compared to
non-disease control animals, vehicle/TNBS treated mice lost weight
throughout the study. In contrast to positive control animals treated with
dexamethasone, 4SC-101 treatment partially normalized this weight loss. By
using western blot analysis, expression of the pro-inflammatory cytokine
IL-17 in distal colon whole cell homogenates was completely inhibited by
4SC-101. Furthermore, immune-histochemistry analyses confirmed
down-regulation of colonic IL-17, as well as IFN-gamma expression.

'These results underline the potential role of the small molecule 4SC-101
in inhibiting IL-17, a key cytokine involved in the regulation of inducing
and mediating responses in inflammatory diseases. This confirms previous
pre-clinical studies which highlighted the potential of 4SC-101 as a novel
immunosuppressive drug for the treatment of intestinal inflammatory
conditions,' said Dr Bernd Hentsch, Chief Development Officer at 4SC. 'We
are eagerly awaiting preliminary results from the Phase IIa trial in
Crohn's Disease patients which will be available by the end of 2009.'

Details of the Presentation

M1658. A Novel Immunosuppressive Drug (4SC-101) Improves TNBS-Induced

Colitis in Mice

Session date and time: 6/1/2009 8:00 AM - 5:00 PM
Session title: Animal Models: Pre-Clinical Treatment of Intestinal
Inflammation
Session type: Individual Presentations
Poster Presenter: Leo R. Fitzpatrick1, Jeffrey S. Small1, George Zhang2,
Ruediger Jankowsky3
1. Pharmacology, Penn State College of Medicine, Hershey, PA, USA. 2. P&G
Pharmaceuticals, Mason, OH, USA. 3. 4SC AG, Martinsried, Germany.

• Ends -

Notes to Editor

About 4SC-101
4SC-101 is 4SC's lead compound and is a novel small molecule of the DMARDs
(disease-modifying anti-rheumatic drugs) class of disease-modifying drugs
recognised for their role in the treatment of autoimmune disorders. The
substance acts as a highly selective inhibitor of the biosynthesis of
pyrimidines which inhibit the proliferation of rapidly multiplying cells,
in particular of lymphocytes, which are important in the regulation of the
immune response in IBD. The drug candidate was discovered by 4SC and has
recently commenced a Phase IIa study in Crohn's Disease. Previously,
4SC-101 has already been successfully tested in a Phase IIa clinical study
in Rheumatoid Arthritis (RA) and will commence a Phase IIb in RA, in
combination with Methotrexate, in 2009. In addition, the broad therapeutic
potential of 4SC-101 has been further substantiated in several pre-clinical
studies in chronic inflammatory bowel diseases, inflammatory skin
conditions and acute transplant rejection.

About Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is a group of inflammatory conditions of
the gastrointestinal tract. The main forms of IBD are Crohn's Disease and
ulcerative colitis, chronic diseases which are constituted by acute-disease
flare ups and symptom-free phases. IBD patients suffer from abdominal pain,
rectal bleeding, diarrhea, weight loss, fatigue and other extra-intestinal
symptoms. Although the causes of IBD are not completely understood, it is
assumed that a disregulated immune response results in inflammatory
mediators that attack the patient's intestinal mucosa and trigger the
symptoms. Crohn's Disease is characterised by an inflammatory affliction of
part of or the whole of the digestive tract and is currently incurable.
Approximately four million people worldwide suffer from various symptoms
and mostly contract the disease between the ages of 20 and 40. Crohn's
Disease leads to a considerable reduction in quality of life, but may also
involve severe complications requiring immediate surgery. Current
therapeutic options for patients are largely limited to the use of
anti-inflammatory steroids applied either systemically or locally for the
treatment of the symptoms, as well as biological (anti-TNF-alpha) agents.

About 4SC
4SC AG (Frankfurt, Prime Standard: VSC/ISIN DE0005753818) is a drug
discovery and development company focused on autoimmune and cancer
indications. The company currently has three clinical programs, with at
least three further clinical trials planned to commence in 2009. The lead
autoimmune compound, 4SC-101, has completed a Phase IIa trial in Rheumatoid
Arthritis, and recently entered a Phase IIa trial in Crohn's Disease. The
lead oncology compound, 4SC-201, recently completed a Phase I trial and
will commence a Phase II trial in Hepatocellular Carcinoma (HCC) in the
second half of 2009. Drug candidates are developed until proof of concept
and subsequently partnered with the pharmaceutical industry in
return for advance and milestone payments as well as royalties.

4SC AG was founded in 1997, has 90 employees, and is listed on the Prime
Standard of the Frankfurt Stock Exchange since December 2005.

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.

For more information please contact:

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

MC Services (Germany/Switzerland)
Stefan Riedel
Tel.: +49 (0) 89 21 02 28 40

The Trout Group (USA)
Chad Rubin
Tel.: +1 646 378 2947
28.05.2009 Financial News transmitted by DGAP

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Language: English
Issuer: 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@4sc.com
Internet: www.4sc.de
ISIN: DE0005753818
WKN: 575381
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart

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