DGAP-Adhoc

4SC AG: 4SC´s cancer compound resminostat meets primary endpoint in Phase II trial in advanced liver cancer (HCC) ahead of schedule

4SC AG  / Key word(s): Miscellaneous

19.01.2012 08:23

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4SC´s cancer compound resminostat meets primary endpoint in Phase II trial
in advanced liver cancer (HCC) ahead of schedule

- Clinical Phase II data to be presented at ASCO Gastrointestinal Cancer
Symposium
- Primary study endpoint met ahead of schedule both in mono and combination
therapy, based on advanced data set analysis
- Resminostat/sorafenib combination therapy halts further disease
progression in two thirds of patients (PFSR 66.6%) and achieves median
progression-free survival (PFS) of 4.6 months
- First successful clinical evaluation of resminostat´s epigenetic mode of
action (resensitisation) in HCC therapy
- Company plans pivotal study programme

Planegg-Martinsried, Germany, 19 January 2012 - 4SC AG (Frankfurt, Prime
Standard: VSC), a discovery and development company of targeted small
molecule drugs for autoimmune diseases and cancer, today published
encouraging efficacy data from the clinical Phase II SHELTER study with the
cancer drug resminostat as a second-line therapy for patients with advanced
liver cancer (hepatocellular carcinoma, HCC) who had exhibited
radiologically proven tumour progression under first-line therapy with
sorafenib (Nexavar(R)) prior to study entry. This open-label, two-arm,
international study investigated the safety and efficacy of resminostat
both as a monotherapy and in combination with sorafenib for this difficult
to treat patient group, for which no approved treatment option is currently
available. According to the data now presented, which is based on an
advanced data set, the primary study endpoint of halting the further
progression of this particularly aggressive cancer in at least 20% of the
patients treated and for at least 12 weeks has been achieved ahead of
schedule in both therapy arms.

The trial´s lead investigator, Prof. Dr. Michael Bitzer of Tübingen
University Hospital, will present the data on 20 January 2012 at 11:45 a.m.
PST (8:45 p.m. CET) as part of the 2012 ASCO Gastrointestinal Cancer
Symposium in San Francisco, CA in a poster, which is available as of now at
www.4sc.de/product-pipeline/publications-posters/resminostat.

The presentation will highlight that resminostat in combination with
sorafenib was able to prevent further progression of the disease for at
least 12 weeks in two-thirds of the currently 15 evaluable patients and