#PROSYNC PROCESS SYNERGY INC TRIAL#
In December 2022 Salarius reported interim clinical results from its Phase 1/2 trial showing that treatment with seclidemstat in combination with topotecan and cyclophosphamide had 60% confirmed disease control and 7.4 months median time to tumor progression for Ewing sarcoma first-relapse patients. Previously Reported Seclidemstat Clinical Data As we gain clarity in those discussions, we intend to provide updates to our investors,” Mr.
#PROSYNC PROCESS SYNERGY INC REGISTRATION#
“The FDA’s decision to remove the clinical hold puts us back on track to engage in dialogue with the FDA on various topics relating to further clinical development of seclidemstat and possible registration pathways. We look forward to working with our clinical trial investigators to resume enrollment with the goal of advancing the development of seclidemstat as a potential treatment option. Ewing sarcoma is a devasting bone and soft tissue cancer with limited treatment options that afflicts children, adolescents and young adults. “I want to commend the team at Salarius for their tireless work to provide the necessary safety and clinical information to assure the FDA of seclidemstat’s compelling risk-benefit profile. “We are confident in seclidemstat’s ability to improve the lives of patients with Ewing sarcoma and are delighted the FDA has removed the partial clinical hold,” said David Arthur, president and chief executive officer of Salarius. The FDA previously granted seclidemstat Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation for Ewing sarcoma.
Food and Drug Administration (FDA) has removed its partial clinical hold on Salarius’ Phase 1/2 Ewing sarcoma clinical trial evaluating seclidemstat, Salarius’ novel oral, reversible, targeted LSD1 inhibitor. ( NASDAQ: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, announces that the U.S. HOUSTON, (GLOBE NEWSWIRE) - Salarius Pharmaceuticals, Inc.
Salarius Plans to Meet with FDA to Discuss Future Development and Potential Registration Pathways
Decision Follows Review of Comprehensive Safety Data Package Submitted by the Company
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