Salarius Pharmaceuticals, Inc. announced that the hematologic cancer Phase 1/2 clinical trial being conducted at the University of Texas MD Anderson Cancer Center (MDACC or MD Anderson) is now listed as active and recruiting on clinical trials.gov - trial NCT04734990. In October 2022, the FDA placed the MDACC investigator-initiated trial under a partial clinical hold following a expected unexpected serious adverse reaction (SUSAR) in the FET-rearranged arm of Salarius' Phase 1/2 trial with seclidemstat in sarcomas. Seclidemstat is a novel oral reversible inhibitor of the LSD1 enzyme and has received fast track, orphan drug and rare pediatric disease designations for Ewing sarcoma from the FDA.

In addition to the MDACC investigator-in initiated clinical trial, seclidemstat has been studied in a company-sponsored Phase 1/2 clinical trial evaluating its use in combination with TC for the treatment of relapsed/refractory Ewing sarcoma. Researchers at MDACC previously reported interim clinical trial results evaluating seclidemstat in combination with azacitidine for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) patients who relapsed or progressed after hypomethylating agent therapy. The Company-sponsored Ewing sarcoma clinical trial focuses on seclidemstat in combination With TC as a treatment for relapsed and refractory Ewing sarcomas.