Corporate | 9 November 2009 07:45
4SC AG / Research Update
09.11.2009
Dissemination of a Corporate News, transmitted by
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Press Release
4SC Announces First Patient Treated in Phase IIb Rheumatoid Arthritis Study
with 4SC-101
- A Small Molecule Inhibitor of DHODH and of Interleukin-17 (IL-17)
Signalling -
Planegg-Martinsried, Germany, 9 November, 2009 - 4SC AG (Frankfurt, Prime
Standard: VSC), a drug discovery and development company, today announced
the dosing of the first patient in its Phase IIb trial evaluating the
combination of 4SC's oral, synthetic, disease-modifying anti-rheumatic drug
(DMARD) 4SC-101 (formerly SC12267) and methotrexate (MTX) in mild to
moderate rheumatoid arthritis (RA) patients.
4SC-101 will be investigated in RA patients in the 'COMPONENT' study
entitled 'A Randomized, Double Blind, Placebo-Controlled, Phase II Study to
Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in
Combination with Methotrexate compared to Methotrexate Alone in Patients
with Rheumatoid Arthritis'. This study will primarily evaluate the efficacy
of the combination of 4SC-101 and MTX in RA patients, compared to
methotrexate alone. The trial will comprise 244 patients in two study arms
of 122 patients each. The first arm will receive 4SC-101 (35 mg) plus MTX,
while the other group will receive placebo plus MTX. 4SC-101 and MTX will
be administered orally for a total study duration of 13 weeks per patient.
Patients eligible for the study must have active RA and have received
weekly doses of MTX (10-25 mg/week) for a minimum of 3 months prior to Day
1 dosing and have received a stable MTX dose of 10-25 mg/week for at least
6 weeks prior to Day 1 dosing.
The primary endpoint of the study is ACR20, a 20% reduction in the number
of swollen and tender joints, and a reduction of 20% in three of the
following five parameters: physician's global assessment of disease,
patient's global assessment of disease, patient's assessment of pain,
C-reactive protein or erythrocyte sedimentation rate, and degree of
physical disability in Health Assessment Questionnaire (HAQ) score. ACR50,
ACR70, DAS28, safety parameters and pharmacokinetics will also be evaluated
as secondary endpoints. The study will be performed at 15
rheumatology-experienced trial centres in Poland, Romania, Bulgaria and the
Czech Republic. 4SC expects completion of enrolment towards the end of
2010.
Dr Ulrich Dauer, Chief Executive Officer of 4SC commented: 'We strongly
believe that 4SC-101 has the potential to become the second-line, synthetic
DMARD of choice for RA patients responding insufficiently to MTX therapy
alone, whilst offering a favourable safety and tolerability profile. Our
expectation is based upon promising data generated in a pre-clinical RA
model using the combination of 4SC-101 and MTX, and on results obtained in
an earlier Phase IIa study using 4SC-101 as mono-therapy treatment in RA
patients. I am delighted that 4SC continues to achieve corporate milestones
in a timely manner to advance important therapies for patients in need of
new treatment options.'
More information about both trials can be found on www.clinicaltrials.gov.
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. 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. 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. DMARDS can be synthetic small molecules
or antibodies.
About 4SC-101
4SC-101 is a novel, orally administered small molecule that is classified
as a synthetic DMARD as it aims to slow the disease progression of
rheumatoid arthritis. The compound also has broad therapeutic potential in
other autoimmune diseases such as inflammatory bowel disease, multiple
sclerosis and inflammatory skin conditions. 4SC-101 inhibits dihydroorotate
dehydrogenase (DHODH), which acts as a highly selective inhibitor of the
biosynthesis of pyrimidines, thereby halting the proliferation of rapidly
multiplying cells, in particular of lymphocytes which are involved in the
pathology of autoimmune disorders. 4SC also recently demonstrated in
pre-clinical tests that 4SC-101 inhibits the expression of IL-17, a
pro-inflammatory cytokine that has a pathogenic role in autoimmune
disorders.
About 4SC
4SC AG (ISIN DE0005753818) is a drug discovery and development company
focused on autoimmune and cancer indications. The company currently has
three clinical programs, with three further clinical trials planned to
commence in 2009. 4SC-101, a small molecule, is in a Phase IIb study in
rheumatoid arthritis as well as in a Phase IIa exploratory study in
inflammatory bowel disease. The company's lead oncology compound, 4SC-201,
a histone deacetylase inhibitor, is in a Phase II trial in hepatocellular
carcinoma and is due to commence a further Phase II trial in Hodgkin's
lymphoma in 2009. Drug candidates are developed 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 93 employees, and is listed on the Prime
Standard of the Frankfurt Stock Exchange since December 2005.
For further information please visit www.4sc.com.
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
Dr. Ulrich Dauer, Chief Executive Officer
Yvonne Alexander, IR & PR
Tel.: +49 (0) 89 70 07 63 66
MC Services (Europe)
Stefan Riedel
Tel.: +49 (0) 89 21 02 28 40
The Trout Group (USA)
Chad Rubin
Tel.: +1 646 378 2947
09.11.2009 Financial News distributed by DGAP. Media archive at www.dgap-medientreff.de and www.dgap.de
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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@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 News DGAP News-Service
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