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Infusion of IL-22Ab Markedly Suppressed Donor Cell Engraftment and Prevented the Disease-Associated Depletion of Host Cells in aGVHD Mice.
HLA loci have also been reported to have impacts on acute graft-versus-host disease (aGVHD),[sup],,,,,,,,,,, which is a major complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Australia-based Mesoblast's intravenous product candidate, MSC-100-IV, has been successful in a pre-specified interim futility analysis in the phase three trial of the product that was used as front-line therapy in children with steroid-resistant acute graft versus host disease (aGVHD), it was reported yesterday.
The endpoints of this study were engraftment, aGVHD and cGVHD, infectious complications, non-relapse mortality (NRM), relapse rate, disease-free survival (DFS), and overall survival (OS).
IL-17A and IL-17F Levels in Blood and Saliva and the Incidence of aGVHD. No association was found between IL17A or IL-17F levels in the blood or saliva samples and the occurrence of systemic cGVHD (data not shown).
Liver biopsy is not particularly helpful in establishing a drug-induced hepatotoxicity, but is important in excluding other causes of liver disease such as SOS, aGVHD and sepsis.
The company plans to broaden its use in adult patients with high-risk steroid-refractory aGVHD.
Acute and cGVHD (aGVHD) were graded by the Seattle criteria.
Several studies on myeloablative conditioning allogeneic transplantation have shown that low whole blood concentrations of CsA during the periengraftment period can strongly affect the incidence of grade 2-4 acute GVHD (aGVHD) [5, 6].
Mesoblast initiated a rolling Biologics License Application (BLA) with the United States Food and Drug Administration (FDA) for remestemcel-L in the treatment of pediatric aGVHD; in preparation for product launch, focus is on inventory and commercial team ramp up.
Mesoblast plans to file for United States FDA regulatory approval of remestemcel-L shortly for the treatment of aGVHD.
Proceeds will be primarily used towards funding the commercialization of MSC-100-IV (remestemcel-L) after this product candidate successfully met its Phase 3 trial's primary endpoint of Day 28 overall response in children with steroid refractory acute Graft versus Host Disease (aGVHD).
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