German Biotech wins FDA Approval for New Liver Cancer Trial

24/02/2016 - 3 minutes

4SC, in Germany, has the FDA’s green light to conduct efficacy trials in the US with a candidate drug against hepatocellular carcinoma.

Munich-based 4SC’s lead candidate, resminostat, is a small-molecule being tested in several trials for some of the deadliest cancers. These include liver – which is also known as hepatocellular carcinoma (HCC).

Resminostat is an inhibitor of histone deacetylase (HDAC), that acts on an epigenetic level (an important part in cancer progression) to reprogram the behavior of cancer cells.

Advancing the trials for HCC in the US is an important milestone in the path towards worldwide commercialization, and will compare the efficacy of resminostat alone and in combination with sorafenib (nexavar).

Sorafenib is currently the only drug for treating HCC. Developed by German Bayer and Onyx Pharma (a subsidiary of US’s Amgen), this drug sparked controversy. The UK’s NHS blocked its use due to its high price, around €3,500 per patient per month, and relatively low efficacy,

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