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4SC Says Its Resminostat Meets Primary Endpoint In Phase II Trial

1/19/2012 2:55 AM ET

4SC AG (FSCGF.PK) 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 prior to study entry.

The open-label, two-arm, international study investigated the safety and efficacy of resminostat both as a monotherapy and in combination with sorafenib for 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 the 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.

In general, resminostat has proven to be safe and well-tolerated. The most frequent side-effects observed were of a gastrointestinal nature.

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by RTT Staff Writer

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