Tuesday, December 05, 2006

4SC AG has received clinical trial approval by authorities and has started the clinical phase IIa study

04 Dec 2006

Announced today the beginning of a clinical phase IIa - study of drug candidate SC12267 for the treatment of patients with rheumatoid arthritis.

PLANNEG, Germany | Dec 04, 2006 | The drug discovery and development company 4SC AG (Frankfurt, Prime standard: VSC) announced today 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 (BfArM) as well as a positive ethics vote from the Medical Faculty of the Friedrich-Alexander-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 of the 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 are genetic as well as autoimmune factors. Besides pain-relieving medicines, so-called disease-modifying medicines (DMARDs = disease modifying anti-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 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 Frankfurt 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 assumptions concerning business plans and goals, products and services and future results or assumptions based on or relating to them. Any statements about the future are subject to risks and uncertainty that are not predictable and are beyond the control of 4SC AG. Many factors may cause the actual results to differ substantially from the results contained in such statements about the future.