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Salarius Pauses Enrollment in Seclidemstat Phase 1/2 Trial

Salarius Pauses Enrollment in Seclidemstat Phase 1/2 Trial

Salarius Pharmaceuticals has paused new patient enrollment in its phase 1/2 clinical trial of seclidemstat for treating people with various forms of sarcoma, after the death of one patient in the trial.

The company notified the FDA of the death, which is now being reviewed by an independent safety review committee.

The trial is aimed at treating Ewing sarcoma, a form of bone cancer, and other sarcomas caused by mutations of FET proteins.

Despite the pause in the study, the company said it plans on releasing interim sarcoma clinical trial results later this year.

About Salarius Pharmaceuticals

Salarius is a cancer-focused biotechnology company developing treatments for patients who need them the most. Salarius technologies correct the dysregulated gene expression of diseased cells and thereby inhibit cancer progression. In certain cancers, the proteins that regulate gene expression become dysregulated and incorrectly turn genes “on” or “off,” which can lead to disease development and progression. Salarius developing two classes of drugs that address gene dysregulation: epigenetic drugs and targeted protein degraders. New technologies have the potential to work in both liquid and solid tumors. Salarius currently in Phase 1/2 trials with epigenetic drug, SP-2577, and in IND-enabling studies with SP-3164, a targeted protein degrader.  Salarius is the recipient of a 3-year $16.1 million Cancer Prevention and Research Institute of Texas (CPRIT) New Company Product Development award, is located in the Jlabs@TMC facility in Houston, Texas.

October 20, 2022

https://www.fdanews.com/
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