Resminostat granted Orphan Drug status against Hodgkin's
According to a press release issued by the company, 4SC (in the business of the discovery and development of oncology products) announced that the United States FDA has granted Orphan Drug status to the firm's oncology compound resminostat for the treatment of Hodgkin's lymphoma.
This is the drug's second such indication. Only recently, the FDA granted Orphan Drug status to resminostat for the treatment of hepatocellular carcinoma (HCC).
Resminostat, an oral pan-histone-deacetylase inhibitor (HDAC, or "H-dack"), is also being explored against colorectal cancer.
The Hodgkin's lymphoma indication comes on the heels of the results of the phase II SAPHIRE study, which considered resminostat as a possible third-line therapeutic intervention in patients with relapsed/refractory Hodgkin's lymphoma. The results, as reported by the company, showed an overall response rate of 33.3 percent, and over half the patients showing a "clinical benefit" from resminostat.
There is currently no consensus on a third-line therapy for relapsed or refractory Hodgkin's lymphoma.
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