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AB Science announces a voluntary hold on the clinical studies of masitinib worldwide.

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Last updated:24th Sep 2021
Published:4th Jun 2021
AB Science SA announced that it has taken the decision to suspend inclusions and treatment initiation in its clinical studies with masitinib worldwide. This decision follows consultation with the French regulatory authorities (ANSM)and other regulatory agencies.

 This decision is relevant to three studies: phase III in mastocytosis (AB15003), phase III in amyotrophic lateral sclerosis (AB19001) and phase II in COVID (AB20001). To this end, AB Science has filed or will file without delay a request for a temporary study hold in all countries where these studies are ongoing. AB Science has identified a potential risk of ischemic heart disease with masitinib. This signal was detected in a retrospective analysis of controlled and unblinded studies of masitinib. Following its own internal procedures, AB Science has decided to suspend inclusion in ongoing studies with masitinib until the investigation of this potential safety issue isfinished. AB Science is working closely with the ANSM and other regulatory agencies.

Condition: Pancreatic Cancer
Type: drug