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Press Release |
4SC AG: 60 Patients in Phase IIa Clinical Trial
Planegg-Martinsried, Germany, 26 April 2007 - German drug
discovery and development company 4SC AG (Frankfurt, Prime Standard),
based in Martinsried near Munich, reports on the on-schedule study progress
of phase IIa of its drug candidate SC12267 for the treatment of rheumatoid
arthritis.
Currently, 60 patients suffering from active rheumatoid arthritis are
participating in this study. Thus, already 50 per cent of the 120 patients
anticipated to take part in this study have been recruited. The study
started in December 2006 and is being carried out in 13 centres across
Germany, Poland and Serbia.
In the three-tiered and placebo-controlled study, patients are given two
doses of SC12267 per day over a three month period and tested for tolerance
and clinical efficacy. Efficacy is tested and evaluated in line with established
international scores like DAS28, ACR20, ACR50 and ACR70.
According to the current schedule, the study results are expected for
the fourth quarter of 2007. Subsequently, a licensing partnership with
a pharmaceutical company is planned for SC12267, to further develop the
product.
"We are very happy with the way the study is proceeding. The co-operation
with the individual study centres is going well and we are confident that
we will be able to keep to our anticipated schedule for the study,"
comments Gerhard Keilhauer, CDO of 4SC AG.
About 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.
About 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 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. There are currently six projects
in the pipeline. The first project on the treatment of rheumatoid arthritis
is currently undergoing clinical phase IIa. Four other product candidates
are in preclinical development and another project is in the research
stage. Furthermore, the company has its technology platform in co-operation
projects with biotech and pharma companies and is already generating initial
revenues.
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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.
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