Corporate | 22 December 2009 07:45
4SC AG / Research Update
22.12.2009
Dissemination of a Corporate News, transmitted by
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Planegg-Martinsried, Germany, 22 December, 2009 - 4SC AG (Frankfurt, Prime
Standard: VSC), a drug discovery and development company focused on
autoimmune and cancer indications, today announced progress in the
initiation of three new clinical trials for its oncology franchise:
- Initiation of a Phase II trial with the oral, pan histone deacetylase
(HDAC) inhibitor resminostat (4SC-201) for the treatment of relapsed or
refractory Hodgkin's Lymphoma (HL)
- First-in-man Phase I trial for the multi-target kinase inhibitor
4SC-203 open for recruitment
- Phase I study protocol accepted by BfArM (German Federal Institute for
Drugs and Medical Devices) for 4SC-205, an oral inhibitor of Eg5
kinesin
After the recent initiation of a first Phase II study with resminostat
(4SC-201) in hepatocellular carcinoma (HCC) earlier this year, this
proof-of-concept study in Hodgkin's Lymphoma (HL) is the second Phase II
trial commenced by 4SC with its pan HDAC inhibitor. This study is a
multi-centre, international clinical trial expected to enrol 33 relapsed or
refractory HL patients in three eastern EU countries. The primary endpoint
of the trial is to evaluate the objective overall response rate (ORR), with
disease assessment being performed on the basis of computed tomography in
combination with positron emission tomography (PET/CT).
Furthermore, the Phase I trial with 4SC-203 is now open for recruitment.
The primary endpoint of this randomised, double-blind, placebo-controlled,
dose-escalating study in healthy volunteers is to investigate the safety
and tolerability of 4SC-203 after single dose administrations. Up to 50
study volunteers will be enrolled in one trial site in Germany. This
compound has shown to be an effective inhibitor of leukemic cell
proliferation, in particular acute myeloid leukaemia (AML) derived cells.
4SC-203 was co-developed with ProQinase GmbH, Freiburg, Germany.
In addition, the Phase I clinical study protocol for 4SC-205 has been
accepted by BfArM. Initiation of enrolment of cancer patients is expected
in January 2010. This open-label, dose-escalating Phase I trial will
recruit up to 30 patients with advanced solid tumours and malignant
lymphomas in two study sites in Germany. The primary endpoint will be the
evaluation of the safety and tolerability of 4SC-205. This compound is a
novel, oral inhibitor of the kinesin-spindle protein Eg5, a motor protein
responsible for proper chromosome separation, inhibition of which causes
cell death as it arrests the cell cycle, the division and duplication of
cells.
Dr Bernd Hentsch, Chief Development Officer of 4SC, commented: '2009 has
been a year of great clinical advancements for 4SC. Within our oncology
franchise, we have positioned our HDAC inhibitor resminostat (4SC-201) in
two Phase II proof-of-concept trials in both solid and haematological
cancer indications. In addition, the transfer of 4SC-203 and 4SC-205 into
clinical development highlights that we continue to support the further
expansion of our pipeline with novel compounds from our proprietary
research. Our approach to develop drug candidates in indications with high
unmet medical needs has the broad potential to create significant and
sustained value for our products, company and patients.'
About 4SC
4SC AG (ISIN DE0005753818) is a small molecule drug discovery and
development company focused on autoimmune and cancer indications. 4SC-101,
a DHODH and IL-17 inhibitor, is currently evaluated in a Phase IIb study in
rheumatoid arthritis (RA) as well as in a Phase IIa exploratory study in
inflammatory bowel disease (IBD). The company's lead oncology compound,
resminostat (4SC-201), a pan histone deacetylase (HDAC) inhibitor, is in a
Phase II trial in hepatocellular carcinoma (HCC) and is due to commence a
Phase II trial in Hodgkin's Lymphoma (HL). Two further oncology compounds
4SC-203 and 4SC-205 are due to commence Phase I trials. 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.
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
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
22.12.2009 Ad hoc announcement, Financial News and Media Release 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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