DGAP-News: 4SC Provides Enrolment Update for Phase IIb Rheumatoid Arthritis Study with Vidofludimus (4SC-101)
(firmenpresse) - 4SC AG / Key word(s): Miscellaneous
16.09.2010 07:30
---------------------------------------------------------------------------
Planegg-Martinsried, Germany - 16 September, 2010 - 4SC AG (Frankfurt,
Prime Standard: VSC), a drug discovery and development company focused on
autoimmune and cancer indications, today announced that the company
anticipates reporting preliminary results from its Phase IIb COMPONENT
trial in patients with mild to moderate rheumatoid arthritis with
vidofludimus, an oral, disease-modifying anti-rheumatic drug (DMARD),
during the first half of 2011. Patients for this trial are currently being
recruited in Poland, Romania, Bulgaria and the Czech Republic across 29
clinical trial sites.
'We are pleased to announce that to date, we have randomised 153 patients
(63% of a targeted total of 244 patients) for the Phase IIb trial in RA
with vidofludimus,' said CEO Ulrich Dauer. 'Based on this current
recruitment speed and the recent expansion of the number of participating
clinical trial centres we expect to present preliminary results in the
first half of 2011.'
Vidofludimus is an oral interleukin-17 (IL-17) and DHODH inhibitor which
has broad application options in autoimmune diseases. It is currently being
evaluated in the COMPONENT study in combination with methotrexate, compared
to methotrexate alone, in rheumatoid arthritis (RA) patients. Vidofludimus
is also being evaluated in a Phase IIa trial in inflammatory bowel disease,
which will report results in Q4 of 2010.
For more information please contact:
4SC AG
Dr. Ulrich Dauer, Chief Executive Officer
Yvonne Alexander, IR&PR
Tel.: +49 (0) 89 70 07 63 0
MC Services (Europe)
Raimund Gabriel
Tel.: +49 (0) 89 21 02 28 40
The Trout Group (USA)
Chad Rubin
Tel.: +1 646 378 2947
Notes to Editor:
About Rheumatoid Arthritis
Rheumatoid Arthritis (RA) is a chronic inflammatory joint disease that
afflicts 0.5 - 1% of the World's 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. Aside from
pain-relieving medicines, so-called disease-modifying medicines (DMARDs =
disease modifying anti-rheumatic drugs) can be used in treatment. DMARDs
can be synthetic small molecules or biologicals (for example antibodies).
They differ from other groups of drugs used in the treatment of rheumatoid
diseases, because 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 joints and provide support for
the repair of changes that have already occurred.
About Vidofludimus
Vidofludimus is a novel, orally administered small molecule for the
treatment of autoimmune disorders such as rheumatoid arthritis and
inflammatory bowel disease. The therapeutic efficacy of vidofludimus is
based on a dual principle. Vidofludimus inhibits the expression of
interleukin-17 (IL-17), a pro-inflammatory cytokine that has a crucial
pathogenic role in a variety of autoimmune diseases. Vidofludimus also
inhibits dihydroorotate dehydrogenase (DHODH), a key enzyme of the
pyrimidine biosynthesis, thereby halting the proliferation of activated T
and B cells which are involved in the pathology of autoimmune disorders.
The combination of two mechanisms of action provides an innovative
therapeutic approach with broad clinical potential in various autoimmune
diseases. Vidofludimus is currently in a Phase IIb study in rheumatoid
arthritis and a Phase IIa study in inflammatory bowel disease.
About the COMPONENT study
The COMPONENT trial is a randomised, double-blind, placebo-controlled,
multi-centre, international Phase IIb study, which is evaluating the
efficacy of vidofludimus with methotrexate, compared to methotrexate alone,
in rheumatoid arthritis (RA) patients. The primary endpoint of this study
is the estimation of ACR20, secondary endpoints are ACR50, ACR70, DAS28,
safety parameters and pharmacokinetics. The trial will include 244 patients
in two study arms. The first arm receives 35mg of vidofludimus, once-daily,
plus methotrexate, the second receives placebo plus methotrexate. The study
duration is 13 weeks and eligible patients must have active RA, 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 for at least 6
weeks prior to Day 1 dosing.
More information about the COMPONENT trial can be found on
www.clinicaltrials.gov.
About 4SC
4SC AG (ISIN DE0005753818) is a drug discovery and development company
focused on autoimmune and cancer indications. Vidofludimus (4SC-101), a
small molecule, is currently in a Phase IIb study in rheumatoid arthritis
and a Phase IIa exploratory study in inflammatory bowel disease. The
company's lead oncology compound, resminostat (4SC-201), a pan histone
deacetylase (HDAC) inhibitor, is in Phase II trials in hepatocellular
carcinoma and Hodgkin's lymphoma. Two further oncology compounds, 4SC-203
and 4SC-205 are in Phase I studies. 4SC develops drug candidates 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.
Founded in 1997, 4SC has 94 employees and has been 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.
16.09.2010 07:30 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
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(at)4sc.com
Internet: www.4sc.de
ISIN: DE0005753818
WKN: 575381
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in München, Düsseldorf, Berlin, Stuttgart
End of Announcement DGAP News-Service
---------------------------------------------------------------------------
Datum: 16.09.2010 - 07:30 Uhr
Sprache: Deutsch
News-ID 32196
Anzahl Zeichen: 0
contact information:
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 245 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DGAP-News: 4SC Provides Enrolment Update for Phase IIb Rheumatoid Arthritis Study with Vidofludimus (4SC-101)"
steht unter der journalistisch-redaktionellen Verantwortung von
4SC AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
