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news.4SC has received the European Medicines Agency (EMA) recommendation for granting orphan medicinal product designation to resminostat which is indicated as a treatment for hepatocellular carcinoma (HCC).
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Presently, the drug is being under investigation in a Phase II SHELTER study as a second-line treatment for advanced hepatocellular carcinoma and in SAPHIRE Phase II study, as a third-line treatment in Hodgkin’s lymphoma.
4SC CEO Ulrich Dauer said both orphan drug designations from the EMA as well as from the FDA emphasize the importance of developing novel therapies in this indication in order to provide effective treatment options to patients suffering from this life-threatening disease.
"We are looking forward to working with both authorities closely as this programme progresses," Dauer said.