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SC12267: Received Clinical Trial Approval & has Started the Clinical Phase IIa Study

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4SC AG has Received Clinical Trial Approval by Authorities and has Started

the Clinical Phase IIa Study

http://www.earthtimes.org/articles/show/news_press_release,29495.shtml

The drug discovery and development company 4SC AG announced the beginning of

a clinical phase IIa -study of drug candidate SC12267 for the treatment of

patients with rheumatoid arthritis.

4SC AG received the necessary approval by the Federal Institute for Drugs

and Medical Devices, Germany as well as a positive ethics vote from the

Medical Faculty of the Friedrich--University Erlangen-Nuremberg,

Germany.

The study will take place at twelve centres in Germany, Poland and Serbia.

The application process for Serbia and Poland is still under authority

review.

" Approval for the phase IIa study on rheumatoid patients is an important

step in our corporate development " , remarked Ulrich Dauer, CEO ofthe 4SC AG.

" With the beginning of this clinical study we have reached a very important

milestone on the road to opening up the market potential of our drug

candidate. "

The participating physicians at centres in Germany are now beginning to

recruit patients. Altogether, 120 patients afflicted with Rheumatoid

Arthritis are included in the study. The study is randomised and

placebo-controlled. SC12267 will undergo random testing using three groups

of patients. Two groups will be administered different dosages of the

substance; the third group will receive a placebo. An analgesic

(paracetamol) will be administered to alleviate arthritis related pain, if

required.

The goal of the study is to find the optimal dosage of the drug candidate

and to examine its therapeutic potency and security. The results of this

study are expected at the end of 2007.

" Quick clinical trial approval by the authorities to start our Phase IIa

study is confirmation of the extraordinary achievement of our development

team, " stressed Gerhard Keilhauer, CDO (Executive Committee for Development)

of 4SC AG.

" With this step we are building a foundation for new and promising

possibilities for treatment of serious autoimmune diseases such as

Rheumatoid Arthritis. "

Rheumatoid Arthritis

Rheumatoid Arthritis is a chronic inflammatory joint disease that afflicts

0.5 - 1% of the population; women are three times more likely to get

arthritis than men are. In the late stage of the disease, irreversible

damage to joint cartilage and bones occurs. Causes of this disease

aregenetic as well as autoimmune factors. Besides pain-relieving

medicines,so-called disease-modifying medicines (DMARDs = disease

modifyinganti-rheumatic drugs) can be used in treatment. These drugs are

used to induce a healing process.

They differ from other groups of drugs used in the treatment of rheumatoid

diseases, since only they are able to stop or reduce damage caused from

chronic inflammation to the joint cartilage or bone. In the most favourable

cases, some DMARDs can also induce repair of damage to joints and provide

support for the repair of changes that have already occurred.

SC12267

SC12267 is a new type of small molecular active agent from the class of

DMARDs used for treatment of autoimmune diseases such as rheumatoid

arthritis or multiple sclerosis. The substance works as a highly selective

inhibitor in the biosynthesis of pyrimidine, which inhibits the

proliferation of fast proliferating cells, in particular the important

lymphocytes used for immune response.

The drug candidate originates in 4SC AG's own research pipeline. In prior

pre-clinical and clinical studies, an outstanding potency and favourable

pharmacokinetic characteristics could already be observed in animal testing,

and a tolerable dosage without relevant side effects on test subjects was

determined.

About 4SC AG

4SC AG (ISIN DE0005753818) has been listed in the Prime Standard of

furt Stock Exchange since 15 December 2005. Founded in 1997 and now

with a staff of 59, the company develops novel drug candidates for

inflammatory diseases and cancer using a cheminformatics based technology

platform.Traditional high throughput screening of therapeutic agents has

been transferred from the lab to the computer. Thus, the company offers

substantial cost and time advantages as well as increased success rates in

drug development.

4SC AG uses its patented technology platform to create a sustainable product

pipeline for active agents that are developed in early clinical phases

( " proof of concept " ) and subsequently result in upfront and milestone

payments as well as participation in sales generated by out-licensed

products to the pharmaceutical industry. The pipeline currently has five

projects, the first of which, on the treatment of rheumatoid arthritis, has

successfully completed clinical phase I. In addition the project pipeline

contains three projects in pre-clinical stage as well as one project in

discovery stage. Furthermore, the company has its technology platform in

co-operation projects with biotech and pharma companies and is already

generating initial revenues.

Legal note

This document may contain forecasts, estimates and assumptionsconcerning

business plans and goals, products and services and future resultsor

assumptions based on or relating to them. Any statements about the futureare

subject to risks and uncertainty that are not predictable and are beyondthe

control of 4SC AG. Many factors may cause the actual results to

differsubstantially from the results contained in such statements about the

future.

For further information, please contact us at: 4SC AG Bettina von Klitzing

Manager Public Relations & Investor Relations Tel.: +49-(0)-89-70-07-63-0

eMail: Bettina.von.klitzing@...

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