Mesoblast Limited has announced a partnership with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) to develop a pivotal trial for the treatment of adults with steroid-refractory acute graft versus host disease (SR-aGVHD). The BMT CTN, which represents centers responsible for 80% of US allogeneic bone marrow transplants, will develop and execute a trial to evaluate Mesoblast’s lead product candidate, Ryoncil, in patients aged 12 and older who are refractory to current treatments. The trial aims to support a marketing application to the US Food and Drug Administration (FDA) based on positive results in a population with no available therapies. Additionally, Mesoblast plans to provide the FDA with additional potency assay data to support the product’s approval for pediatric indications.
The partnership with BMT CTN is significant as it provides access to a reputable network of transplant centers and reinforces the potential for Ryoncil to become an approved therapy for adults suffering from SR-aGVHD. Mesoblast’s CEO, Silviu Itescu, expressed his pleasure at partnering with BMT CTN to address the unmet medical needs of patients with this severe inflammatory condition. Mesoblast is a world leader in the development of allogeneic cellular medicines for inflammatory diseases and has a robust portfolio of product candidates in late-stage development. If successful, Ryoncil could become a life-saving treatment for adults and adolescents with SR-aGVHD.
