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MaaT Pharma Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD

 

 

 

 

Lyon, France, April 09, 2019 – MaaT Pharma announced today that the independent Data and Safety Monitoring Board (DSMB) recommended the continuation, without amendment, of the ongoing Phase II HERACLES study (NCT03359980). The HERACLES trial inverstigates the use of lead biotherapeutic MaaT013 in steroid-resistant, gastrointestinal-predominant, acute Graft-versus-Host-Disease (SR GI aGvHD) after allogeneic Hematopoietic Stem-Cell Transplantation (allo-HSCT). The second review assessed the safety of MaaT013 after 10 patients treated, reinforcing the absence of safety issues during the trial as confirmed after the first review. Enrollment of patients in the trial continues as planned with additional sites recently opened in Germany and Italy. As of today a total of 13 patients have been treated in the protocol.

 

 

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