Corporate | 7 January 2011 07:30
4SC AG / Key word(s): Research Update
07.01.2011 / 07:30
Planegg-Martinsried, Germany, 7 January, 2011 - 4SC AG (Frankfurt, Prime
Standard: VSC), a drug discovery and development company, today announced
successful completion of its First-in- Man Phase I study in healthy
volunteers with the multi-target kinase inhibitor 4SC-203.
In this randomised, double-blind, placebo-controlled, Phase I dose
escalation study the safety, tolerability, and pharmacokinetics of 4SC-203
was assessed in 60 healthy, male volunteers aged 20 to 46 years. Cohorts of
eight subjects each, radomised in a 6:2 ratio (active:placebo), received
ascending single intravenous doses of the compound. The dose range
comprised 0.041 to 2.5 mg/kg, which corresponds to a total dose of 2.5 to
150 mg for an individual of 60 kg body weight.
4SC-203 proved to be safe and was well tolerated by all subjects. Only 33%
of volunteers experienced adverse events, which were all graded of mild
intensity with the exception of three events which were moderate. No
dose-dependent increase in the number of Treatment-Emergent Adverse Events
and no Serious Adverse Event were observed. No changes in physical and
laboratory parameters were recorded and no target organ toxicity occurred.
Pharmacokinetics of 4SC-203 in the investigated concentration range of the
applied doses displayed the expected dose-dependent increase, providing an
excellent basis for the further clinical development of 4SC-203.
4SC-203 is an intravenously administered, small molecule, multi-target
kinase inhibitor. In vitro and in vivo studies have shown a strong
selectivity profile against FLT3 and FLT3 mutants. In addition, selectivity
was shown against VEGF receptors, which are required for angiogenesis, the
formation of new blood vessels necessary for the progression of solid
tumours. The compound is being assessed in further preclinical testing in
order to establish its potential in various indications, including the
treatment of solid tumours. This compound was discovered in collaboration
with ProQinase GmbH, Freiburg, Germany.
More information about this trial can be found on www.clinicaltrials.gov.
-Ends-
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 Phase II development in rheumatoid
arthritis and inflammatory bowel disease (IBD), for which positive results
from a Phase IIa study were recently reported. 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.
For more information please contact:
4SC AG
Yvonne Alexander
Investor & Public Relations
Tel.: +49 (0) 89 70 07 63 66
MC Services (Europe)
Raimund Gabriel
Tel.: +49 (0) 89 21 02 28 40
The Trout Group (USA)
Chad Rubin
Tel.: +1 646 378 2947
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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
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