DGAP-News: 4SC Reports New Data from the Clinical Trials with Oral Pan-HDAC Inhibitor Resminostat
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Miscellaneous
4SC Reports New Data from the Clinical Trials with Oral Pan-HDAC
Inhibitor Resminostat
23.06.2011 / 07:30
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4SC Reports New Data from the Clinical Trials with Oral Pan-HDAC Inhibitor
Resminostat
- Update on Phase II SHELTER and Phase I/II SHORE trials in hepatocelullar
and colon cancer presented at the ESMO 13th World Congress on
Gastrointestinal Cancer -
Planegg-Martinsried, Germany, 23 June, 2011- 4SC AG (Frankfurt, Prime
Standard: VSC), a discovery and development company of targeted small
molecule drugs for autoimmune diseases and cancer, today announced data
from the ongoing oral resminostat Phase II SHELTER trial in hepatocellular
carcinoma (HCC) and from the ongoing Phase I/II SHORE trial in KRAS-mutant
colorectal carcinoma (CRC) during two poster presentation sessions at the
ESMO 13th World Congress on Gastrointestinal Cancer in Barcelona, Spain,
from 22-25 June, 2011.
The poster titled 'Clinical update on the Phase I/II trial of HDAC
Inhibitor Resminostat in Patients with Sorafenib-Resistant Hepatocellular
Carcinoma (HCC) - the SHELTER Study' includes new interim data from the
Phase I/II SHELTER study in HCC. The data confirm previously reported
trends with regard to clinical activity. The trial is evaluating up to
70HCC patients, which must show a radiologically proven progression of
their disease under first line therapy with sorafenib (Nexavar) prior to
entry into the study. After 6 weeks of study therapy, eleven out of
eighteen (61%) patients assessed to date show confirmed tumor
stabilization. After 12 weeks of study therapy, eight out of 16 (50%)
patients assessed displayed continuous stable disease either on sorafenib
and resminostat or resminostat alone. The study medication continues to be
safe and well tolerated. This study is expected to report Phase II results
in 2011.
The poster titled 'SHORE: a Phase I/II Study of Resminostat, an Oral
Histone Deacetylase Inhibitor (HDACi), in Combination with FOLFIRI as
Second-Line Treatment in KRAS Mutated Colorectal Cancer (CRC) Patients',
includes data from the study in which resminostat is applied in combination
with the colon cancer chemotherapy regimen FOLFIRI in 80 patients. The
first dose level of 200mg, one of four dose levels planned, was
successfully completed in the dose escalation portion of the trial. No
dose-limiting toxicities were observed when 200 mg of resminostat and the
standard dose of the FOLFIRI regimen were administered in combination. The
dose escalation continues according to the study protocol. The Phase I/II,
dose-ranging part of the study is expected to conclude in 2012.
'We are very pleased with the new, positive data we have been able to
present on our lead oncology compound resminostat today. As SHELTER and
SHORE are open-label studies, we are able to gain updates from the trials
as we evaluate the compound in various doses and in combination with
established standard treatments,' said Ulrich Dauer, CEO of 4SC.
'Resminostat is already being evaluated in three cancer indications, and we
are expecting to report Phase II results for both, the treatment of
hepatocelluar cancer and Hodgkin's lymphoma, this year.'
Abstract Title: 'Clinical update on the Phase I/II trial of HDAC Inhibitor
Resminostat in Patients with Sorafenib-Resistant HepatocellularCarcinoma
(HCC) - the SHELTER Study'
Poster Presentation Time:
Thursday, 23 June 2011, 10:30 - 11:00 and 16:00 - 16:30
Poster presenter:
M. Bitzer, M. Horger, T. Ganten, M.P. Ebert, J. Siveke, M.A. Woerns, M.M.
Dollinger, G. Gerken, M.E. Scheulen, A. Mais, R. Jankowsky, B. Hauns, B.
Hentsch, U.M. Lauer
Abstract Title:
'SHORE: a Phase I/II Study of Resminostat, an Oral Histone
Deacetylase Inhibitor (HDACi), in Combination with FOLFIRI as Second-Line
Treatment in KRAS Mutated Colorectal Cancer (CRC) Patients'
Poster Presentation Time:
Friday, 24 June 2011, 10:30 - 11:00 and 16:30 - 17:00
Poster Presenter:
S. Bauer, H. Schulze-Bergkamen, D. Jäger, F. Mayer, M. Bitzer, B. Hauns, K.
Resemann, R. Jankowsky, A. Mais, H. Kohlhof, B. Hentsch
- Ends -
For more information please contact:
4SC AG
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
About Resminostat
Resminostat (4SC-201) is an oral pan-histone-deacetylase (HDAC) inhibitor.
HDAC inhibitors modify the DNA structure of tumour cells to cause their
differentiation and programmed cell death (apoptosis) and are therefore
considered to offer a mechanism of action that has the particular potential
to halt tumour progression and induce tumour regression. Resminostat is
currently being investigated in the Phase II SHELTER study as a second-line
treatment for advanced hepatocellular carcinoma, in the Phase I/II SHORE
study as a second-line treatment in colorectal cancer in KRAS-mutant
patients, as well as a Phase II study in third-line treatment in Hodgkin's
lymphoma in the Phase II SAPHIRE trial.
About 4SC
4SC (ISIN DE0005753818) discovers and develops targeted, small-molecule
drugs for the treatment of diseases with a high unmet medical need in
various autoimmune and cancer indications. These drugs are intended to
provide patients with innovative treatment options that are more tolerable
and efficacious than existing therapies, and provide a better quality of
life. The company's balanced pipeline comprises promising products that are
in various stages of clinical development. 4SC's aim is to generate future
growth and enhance its enterprise value by entering into partnerships with
leading pharmaceutical companies.
Founded in 1997, 4SC currently 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.
End of Corporate News
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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(at)4sc.com
Internet: www.4sc.deISIN: 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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129445 23.06.2011
Datum: 23.06.2011 - 07:30 Uhr
Sprache: Deutsch
News-ID 34453
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