Salarius Pharma says FDA lifts partial clinical hold on Phase 1/2 Ewing sarcoma clinical trial for seclidemstat
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- Salarius Pharma (NASDAQ:SLRX) announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on its Phase 1/2 Ewing sarcoma clinical trial, which is evaluating the efficacy of seclidemstat.
- Seclidemstat, Salarius Pharma's novel oral, reversible, targeted LSD1 inhibitor, has received Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA.
- In October, Salarius Pharma, a clinical-stage biotech, announced that it would temporarily halt the enrollment of new patients in the Phase 1/2 clinical trial for their lead asset, seclidemstat, in connective tissue cancer, following the death of a study participant.
- Following the death of a patient with metastatic FET-rearranged sarcoma due to a suspected unexpected serious adverse reaction (SUSAR), the company made the decision to pause enrollment in the Phase 1/2 trial for its lead asset seclidemstat in connective tissue cancer.
- Press Release