Corporate | 21 January 2010 07:45
4SC AG / Research Update
21.01.2010
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Press Release
4SC Announces Start of Dosing in First-in-Man Phase I Study with 4SC-203
Planegg-Martinsried, Germany, 21 January, 2009 - 4SC AG (Frankfurt, Prime
Standard: VSC), a drug discovery and development company, today announced
the start of dosing in a First-in-Man Phase I study in healthy volunteers
evaluating 4SC-203, a novel multi-target kinase inhibitor, with particular
specificity against selected kinases, including FMS-like tyrosine kinase 3
(FLT3), FLT3 mutants and vascular endothelial growth factor receptors
(VEGF-R).
This randomised, double-blind, placebo-controlled, dose-escalation study
investigates the safety, tolerability, pharmacokinetics and
pharmacodynamics of 4SC-203, administered as single dose intravenously, in
50 volunteers and comprises seven treatment cohorts. In the first cohort,
an initial low dose of 4SC-203 has been applied for safety observations.
Subsequent dose escalating cohorts will include eight volunteers each
randomised at a 4SC-203 to placebo ratio of 6:2. The trial is expected to
last for approximately six months and to report results in 2010.
4SC-203 is a multi-target kinase inhibitor which has a unique selectivity
profile against FLT3, FLT3 mutants and VEGF-Receptors in both in vitro and
in vivo studies. FLT3 represents an attractive therapeutic target in acute
myeloid leukaemia (AML), as this kinase is over-expressed in patients with
this disease. Furthermore, FLT3 mutations can be identified in
approximately one third of these patients, which are associated with a
dismal prognosis due to a high relapse rate, for which there currently is
no treatment option. In addition, as 4SC-203 has been shown to inhibit
vascular endothelial growth factor receptors (VEGF-R) which are responsible
for stimulating the cellular responses required for angiogenesis (the
growth of new blood vessels necessary for progression of solid tumours).
This compound was co-developed with ProQinase GmbH, Freiburg, Germany
(www.proqinase.com).
Dr Bernd Hentsch, Chief Development Officer of 4SC commented: 'The
commencement of this first-in-man Phase I trial with 4SC-203 which was
developed by 4SC from discovery through to development, highlights our
ability to build a broad and diversified pipeline. Our oncology development
strategy remains to address unmet medical needs and market opportunities by
identifying and progressing multiple drug candidates into the clinic that
offer different molecular approaches and mode-of-actions, and that may
therefore be applicable for a broader range of different tumour diseases. '
More information about this trial can be found on www.clinicaltrials.gov.
About 4SC-203
4SC-203 is a novel multi-target kinase inhibitor. In preclinical testing
the compound has shown unique and strong selectivity against a set of
kinases including FLT3, FLT3 mutants and VEGF-receptors. This target
activity profile holds particular promise since FLT3 is regarded as a
specifically important cancer target in AML. Generally, FLT3 is involved in
the growth and maturation of normal blood cells, however, in AML patients
this kinase frequently gets overexpressed or activated by mutation, causing
uncontrolled cell growth and this way contributes to the progression to
cancer. With the additional inhibition of VEGF receptor tyrosine kinases,
4SC-203 may also inhibit angiogenic processes and could therefore also be
applicable for the therapy of solid cancer types.
About AML
Acute myeloid leukaemia (AML), also known as acute myelogenous leukaemia,
is the most common leukemic cancer affecting adults. It is a fast-growing
disease characterised by the abnormal growth of a type of white, myeloid,
blood cell in bone marrow which hinders the development of normal blood
cells. The symptoms of the disease include fatigue, easy bruising, bleeding
and increased risk of infection. AML causes approximately 1.2% of cancer
deaths in the USA; however it is increasing due to the ageing population.
The treatment of this disease is categorised into three stages: induction,
post remission and post relapse therapy. Treatment is initially and
subsequently chemotherapy, eventually combined or followed by hematopoietic
stem cell transplantation. Although remission can be induced in most
patients, only approximately one third of patients survive more than five
years.
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 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. 4SC-203, a multi-kinase
inhbitor is in a Phase I study. 4SC-205, a further oncology compound, is
due to commence a Phase I study shortly. 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 60
MC Services (Europe)
Stefan Riedel
Tel.: +49 (0) 89 21 02 28 40
The Trout Group (USA)
Chad Rubin
Tel.: +1 646 378 2947
21.01.2010 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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