World News: 11:00 GMT Wednesday 14th August 2019. [Mesoblast Limited via Globe Newswire via SPi World News]
NEW YORK, Aug. 14, 2019 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that it intends to provide its allogeneic cell therapy product candidate remestemcel-L for evaluation under an investigator-initiated Investigational New Drug (IND) submission as a potential treatment in children with steroid-refractory graft-versus-host disease (GVHD). The lead investigator will be Dr Joanne Kurtzberg, Jerome Harris Distinguished Professor of Pediatrics and Professor of Pathology, and Director, Pediatric Blood and Marrow Transplant Program at Duke University Medical Center.
In both and forms of GVHD, the donated bone marrow stem cells view the recipient’s body as foreign, and attack the body causing significant morbidity and mortality. GVHD usually manifests within 100 days following a transplant while GVHD generally manifests later (>100 days), and the two may occur separately or within the same patient.
The incidence of GVHD is increasing and occurs in 30-70% of recipients of both related and unrelated bone marrow transplants. There are no therapies approved by the United States Food and Drug Administration (FDA) in the 50% of children with GVHD who fail steroids. Mesenchymal stem cells have been used successfully in patients with steroid-refractory GVHD and have been reported to result in durable responses in up to 75% of patients.
Dr Kurtzberg said: “Given my experience with achieving successful outcomes with remestemcel-L in children with steroid-refractory GVHD, I look forward to evaluating the treatment’s potential as salvage therapy in GVHD, where there remains a significant unmet need.”
Earlier this year, Mesoblast initiated filing of a rolling submission for a Biologics License Application (BLA) to the FDA for the use of remestemcel-L in children with steroid-refractory GVHD. This BLA submission is based on a successful Phase 3 trial in 55 children with steroid-refractory GVHD and supporting results from an Expanded Access Program (EAP) in 241 children. Dr Kurtzberg was the Principal Investigator in both trials.
1. .2. Grube et al. Biol Blood Marrow Transplant: 2016; 22 (11): 1781-1793. Went et al. Bone Marrow Transplantation 2010; 45:1732-1740.4. Shai et al. Blood 2013; 122:3294.5. von Bahr et al. Blood 2015; 126:3138.
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Globe Newswire: 11:00 GMT Wednesday 14th August 2019
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