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news.4SC, a German-based developer of targeted small-molecule drugs, has received orphan drug status for its oncology drug resminostat as a treatment for Hodgkin's lymphoma (HL) from the US Food and Drug Administration (FDA).
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The results from a Phase II Saphire study investigating resminostat as a third-line treatment in relapsed/refractory HL patients, showed a 33.3% overall response rate and 54.5% of patients achieving a clinical benefit from the treatment with resminostat.
4SC CEO Ulrich Dauer said the combined final data set of the Saphire study in HL and the Shelter study in HCC, which is anticipated by the end of this year, should encourage them to discuss their plans for a pivotal development programme for resminostat with regulatory authorities and potential partners in the near future.