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ARTICLE | Clinical News

Mesoblast's MSCs meet in Phase III for acute GvHD

February 22, 2018 10:44 PM UTC

Mesoblast Ltd. (ASX:MSB; NASDAQ:MESO) said remestemcel-L (MSC-100-IV) met the primary endpoint in a Phase III trial to treat steroid-refractory acute graft-versus-host disease (GvHD). The company said full data from the trial, which are expected next quarter, “may provide sufficient clinical evidence” to seek accelerated approval of the candidate in the U.S. Mesoblast said it expects to submit regulatory applications for remestemcel-L late this year or early next year.

On the trial's primary endpoint, remestemcel-L led to an overall response rate (ORR) at day 28 of 69% vs. 45% for historical controls (p=0.0003). A complete response was defined as resolution of acute GvHD in all involved organs and a partial response was defined as organ improvement of at least one stage without worsening of any other organ. In 50 evaluable patients with 100 days of follow-up, the survival rate was 78%...

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