After Patient Death, Salarius Stops Enrollment In Seclidemstat Trial For Soft Tissue Cancer

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  • Per protocol design, Salarius Pharmaceuticals Inc SLRX is voluntarily pausing new patient enrollment in the company's Phase 1/2 trial of seclidemstat as a treatment for Ewing sarcoma and FET-rearranged sarcomas.
  • Ewing sarcoma is a rare type of cancer that occurs in bones or the soft tissue around the bones.
  • The pause in new patient enrollment is due to a metastatic FET-rearranged sarcoma patient death that was classified as a suspected unexpected serious adverse reaction (SUSAR). 
  • Upon review of the SUSAR and available information by the company's independent Safety Review Committee for the clinical trial, patients currently receiving seclidemstat treatment may continue treatment after consulting with their physician.
  • Salarius communicated the details of the SUSAR to the FDA and intends to analyze the available data further. Salarius plans to release interim sarcoma clinical trial results later this year.
  • In January, Salarius agreed to acquire an oral, small molecule targeted protein degradation portfolio against cancer from DeuteRx LLC that includes a lead drug candidate that Salarius has renamed SP-3164 (formerly DRX-164).
  • Price Action: SLRX shares are down 26.6% at $3.67 during the premarket session on the last check Tuesday.
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