Print Page     Close Window     
6-K
MESOBLAST LTD filed this Form 6-K on 08/31/2018
Entire Document
 

Slide 17

Operational Update: MSC-100-IV (remestemcel-L) product candidate for steroid refractory aGVHD | Phase 3 study evaluated remestemcel-L in 55 children to improve overall response rate and survival 89% of children had grade C/D disease, the most severe form and historically associated with up to 90% mortality Study successfully met the primary endpoint of improved Day 28 Overall Response (OR) 69% vs 45% protocol-defined historical control rate (p=0.0003) Day 100 Overall Survival 75%, with 87% survival in Day 28 responders Day 180 survival results expected shortly Remestemcel-L safe and infusions well tolerated1 Findings consistent with previous results in 241 SR-aGVHD children under expanded access who failed to respond to multiple biologic agents2 Data on file from Protocol 280 Clinical Study Reports. Kurtzberg J. et al. Effect of Human Mesenchymal Stem Cells (remestemcel-L) on Clinical Response and Survival Confirmed in a Large Cohort of Pediatric Patients with Severe High-Risk Steroid-Refractory Acute Graft Versus Host Disease. BBMT. 2016; 22.


Copyright © 2015 Mesoblast Inc.