4SC AG — Regulatory Filings 2011

Jun 23, 2011

News Details

Corporate | 23 June 2011 07:30

4SC Reports New Data from the Clinical Trials with Oral Pan-HDAC Inhibitor Resminostat

4SC AG / Key word(s): Miscellaneous

23.06.2011 / 07:30

**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 13 th 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 13 th 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 Hepatocellular Carcinoma (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.

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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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