- Salarius Pharmaceuticals Inc (NASDAQ: SLRX) has completed the dose-escalation stage and established the recommended Phase 2 dose for its ongoing Phase 1/2 trial evaluating its lead candidate, seclidemstat, in relapsed/refractory (R/R) Ewing sarcoma.
- It is a rare type of cancer in bones or the soft tissue around the bones.
- Data from the dose-escalation portion demonstrated that seclidemstat had a manageable safety profile. The recommended dose for the expansion stage has been established. PK data indicated that treatment at the recommended dose achieved plasma concentrations above levels where seclidemstat demonstrated activity in preclinical studies.
- As previously reported, a refractory Ewing sarcoma patient treated with single-agent seclidemstat for six cycles (a cycle is 28 days) demonstrated a reduction in prospectively defined target lesions starting at the end of cycle 2 with further target lesion tumor shrinkage through the end of cycle 4 and cycle 6 (over 75% tumor shrinkage).
- Additionally, in a small subset of Ewing-related sarcoma patients with progressive disease, the median time to progression was above the benchmarks established for single-agent activity in the advanced, relapsed soft tissue sarcoma setting.
- Data readouts are expected towards the end of this year and early next year.
- Price Action: SLRX stock gained 5.9% at $2.81 in market trading hours on the last check Wednesday.
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