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Press Release

4SCs Anti-Cancer Drug Resminostat achieves Median Overall Survival of 8.0 Months in Second-Line Advanced Liver Cancer (HCC) Patients

- Overall survival (OS) data from Phase II SHELTER trial in advanced liver cancer (HCC)to be presented at 2012 ILCA Conference in Berlin, Germany, on 16 September 2012

- Median OS of 8.0 months in resminostat/sorafenib combination group is highest OS value to date in clinical trials in comparable second-line HCC patient populations

- OS correlates with previously reported median progression-free-survival of 4.7 months

- Innovative epigenetic mode of action (tumour re-sensitisation), convincing signals of efficacy and favorable safety profile underline further development of resminostat as a combination therapy with sorafenib in first- and second-line advanced HCC

- Pivotal Phase III trial in second-line HCC planned to start by mid 2013 preferably with a partner

Planegg-Martinsried, Germany, 13 September 2012 - 4SC AG (Frankfurt, Prime Standard: VSC), a discovery and development company of targeted small molecule drugs for autoimmune diseases and cancer, announced today the publication of convincing overall survival data from a Phase II study with its lead anti-cancer drug resminostat applied as a novel combination therapy approach with sorafenib in second-line advanced liver cancer at the 2012 annual meeting of the International Liver Cancer Association in Berlin, Germany, on 16 September 2012.

The international, open-label, two-arm SHELTER study enrolled patients with advanced liver cancer (hepatocellular carcinoma, HCC) who had shown proven radiological tumor progression under first-line therapy with the cancer drug sorafenib (Nexavar(R). The study investigated safety and efficacy of resminostat as a monotherapy and in combination with sorafenib in this patient group with currently no approved treatment option.

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DGAP-News: Press Release: 4SC´s Anti-Cancer Drug Resminostat achieves Median Overall Survival of 8.0 Months in Second ...