4SC AG (FSCGF.PK) announced 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 September 16, 2012. The international, open-label, two-arm SHELTER trial enrolled patients with advanced liver cancer who had demonstrated proven radiological tumor progression under first-line therapy with the cancer drug sorafenib.
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.
Final median overall survival of 8.0 months was determined in the resminostat/sorafenib combination 'intend-to-treat' population, i.e. all study patients who were treated with the combination of 600 mg resminostat total daily dose and 400 mg sorafenib TDD. According to the company, the data for the resminostat/sorafenib combination therapy showed a progression-free survival rate after 12 weeks of treatment of 70.0% and a median PFS of 4.7 months.
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