Salarius Pauses Enrollment in Phase 1/2 Study in Rare Cancer After Patient Death

Salarius Pharmaceuticals said that per its protocol design, it 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 following the death of a patient with metastatic FET-rearranged sarcoma that was classified as a suspected unexpected serious adverse reaction.

Photo: David Arthur, CEO of Salarius

Upon review of the death 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 suspected unexpected serious adverse reaction (SUSAR) to the U.S. Food and Drug Administration and said it intends to further analyze the available data with the goal of understanding how best to proceed and restart enrollment as soon as possible. Salarius continues to plan to release interim sarcoma clinical trial results later this year.

“Patient safety is our primary concern, and this is reflected in the design of our clinical trial protocol, which automatically paused enrollment based upon this SUSAR,” said David Arthur, CEO of Salarius. “Unfortunately, pauses to enrollment occur in early-stage drug development, but these pauses allow time to understand new data and adjust clinical protocols and development plans as needed. We plan to restart enrollment as soon as possible.” 

Seclidemstat, Salarius’ lead candidate, is being studied as a potential treatment for pediatric cancers, sarcomas, and other cancers with limited treatment options.

Seclidemstat is a differentiated inhibitor of the LSD1 enzyme, a well-validated target for both hematological and solid tumors. It inhibits LSD1’s demethylation and scaffolding properties, representing a viable therapeutic option for patients who need it the most. The FDA granted Salarius fast track, orphan drug and rare pediatric disease designations for seclidemstat in Ewing sarcoma. Salarius is also exploring seclidemstat’s potential in several cancers with high unmet medical need. The company has received financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma clinical program.

Author: Rare Daily Staff