Corporate | 9 December 2008 08:30
4SC AG / Miscellaneous
Release of a Corporate News, transmitted by DGAP - a company of EquityStory
AG.
The issuer / publisher is solely responsible for the content of this announcement.
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Planegg-Martinsried, 9. December 2008 – The Martinsried-based drug
discovery and development company 4SC AG (Frankfurt, Prime Standard: VSC)
announced today that the last patient had been included in the phase-I
clinical trial with drug candidate 4SC-201 and had already tolerated the
first two cycles of treatment with a daily dose of 800 mg well. Since no
dose-limiting toxicity occurred, patient recruitment for this phase-I test
series as well as the clinical dose finding for future phase-II trials
based upon it were concluded.
4SC-201 is a drug candidate from the class of histone deacetylase (HDAC)
inhibitors, which 4SC AG is developing for the treatment of cancer. In the
phase-I clinical trial with this drug candidate, a total of 18 cancer
patients were treated. On the one hand, the objective of the study is to
evaluate safety, tolerability and pharmacokinetics as well as, on the other
hand, determine the maximum tolerated dose and dose-limiting toxicity and
examine the pharmacodynamics and therapeutic efficacy of
4SC-201.
The first available study results prove that 4SC-201 can be safely
administered orally, is highly tolerated and shows a particularly positive
pharmacological profile. To date, in several patients with different
tumour types a disease stabilisation has been observed. Two patients in
particular who continued treatment with 4SC-201 in an optional subsequent
therapy setting that went beyond the main study treatment and which is
still ongoing, were already able to reach a total therapy duration of up to
eight months, accompanied by a stabilisation of the cancer. The final
evaluation of all data collected from this study is planned for the first
quarter of 2009.
'We are very pleased that the last patient included in the study also
tolerated the treatment with 4SC-201 well and that we can thus reconfirm
the results published in October,' said Dr Bernd Hentsch, Chief Development
Officer at 4SC AG. 'The evaluation of the data from this phase-I trial will
make it possible for us to derive the doses for the further development of
4SC-201. We are now in a position to substantiate and implement our
phase-II trial plans with this drug.'
4SC AG plans to start a phase-II clinical trial in a selected indication of
solid tumours in the first half of 2009.
About 4SC AG:
4SC AG (ISIN DE0005753818) has been listed in the Prime Standard of
Frankfurt Stock Exchange since 15 December 2005. Founded in 1997 and now
with a staff of 83 employees, the company develops novel drug candidates
against inflammatory diseases and cancer. 4SC AG utilises its patent
protected platform, to create a sustainable project pipeline of drug
candidates, which are to be developed up to clinical efficacy in early
clinical phases ('proof of concept') and subsequently partnered with the
pharmaceutical industry in return for advance and milestone payments as
well as royalties. There are currently eight projects in the development
pipeline and a rich pool of further discovery projects. Clinical phase IIa
for the first project for the treatment of rheumatoid arthritis has already
successfully been completed. An additional project for the treatment of
various cancers is near completion of a clinical phase I trial. Further
projects are in advanced pre-clinical stages.
Further information is to be found at 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:
Bettina von Klitzing
Manager Investor Relations & Public Relations
4SC AG
Tel.: +49 (0) 89 70 07 63 - 0
Bettina.von.Klitzing@4sc.com
09.12.2008 Financial News transmitted by DGAP
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Language: English
Issuer: 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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