Mesoblast moving remestemcel-L into chronic GVHD pivotal trial


Mesoblast (NASDAQ:MESO; ASX:MSB) achieved clinically meaningful outcomes in all three treated patients, two children and one adult, within 28 days after two infusions of its allogeneic cell therapy product candidate, remestemcel-L, for steroid-refractory chronic graft versus host disease (GVHD).

On the basis of these outcomes, the investigator-initiated collaboration will be expanded to evaluate remestemcel-L in a pivotal trial for chronic GVHD.

“We are delighted with these initial efficacy outcomes using remestemcel-L as first-line therapy in steroid-refractory chronic graft versus host disease, where there is a major unmet medical need for a safe and effective therapy,” lead investigator, Dr. Joanne Kutzberg, said in a statement.

Chronic GVHD occurs in 30% to 70% of recipients of an allogeneic bone marrow transplant. More than 30,000 patients worldwide undergo an allogeneic bone marrow transplant annually, primarily during treatment for blood cancers, and these numbers are increasing. The prevalence of chronic GVHD in the U.S. is more than 14,000 patients, with an estimated annual patient medical cost of about $300,000.