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news.4SC has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its oncology drug resminostat (4SC-201) as a treatment for hepatocellular cancer (HCC).
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Resminostat, which is an oral pan-histone-deacetylase (HDAC) inhibitor, is currently being evaluated in Phase II SHELTER study as a second-line treatment for advanced hepatocellular carcinoma as well as under investigation as a third line treatment for Hodgkin’s lymphoma in Phase II study SAPHIRE trial.
In addition, the Phase I/II SHORE study is evaluating resminostat as a second-line therapy setting in colorectal cancer in KRAS-mutant patients.
4SC CEO Ulrich Dauer said their strategy for the development of resminostat, an oral-HDAC inhibitor, has been to evaluate its mechanism of action in three cancer indications: hepatocellular carcinoma, Hodgkin’s lymphoma and colorectal cancer.
"We are looking forward to finalizing results from the ongoing Phase II SHELTER trial in 2011, from which we have so far announced encouraging interim data due to its open-label structure," Dauer said.