July 6, 2020 / 8:48 PM / a month ago

BRIEF-Cellectis SA Says Melani-01 Trial Has Been Placed On Clinical Hold By U.S. FDA

July 6 (Reuters) - Cellectis SA:

* CELLECTIS SA - MELANI-01 TRIAL HAS BEEN PLACED ON CLINICAL HOLD BY U.S. FDA

* CELLECTIS SA - CLINICAL HOLD INITIATED FOLLOWING SUBMISSION OF SAFETY REPORT REGARDING ONE PATIENT ENROLLED IN MELANI-01 STUDY AT DOSE LEVEL 2

* CELLECTIS SA - PATIENT ENROLLED IN MELANI-01 STUDY AT DL2 EXPERIENCED FATAL TREATMENT-EMERGENT ADVERSE EVENT OF CARDIAC ARREST

* CELLECTIS SA - WORKING CLOSELY WITH FDA TO ADDRESS REQUESTS INCLUDING CHANGES TO MELANI-01 CLINICAL PROTOCOL DESIGNED TO ENHANCE PATIENT SAFETY

* CELLECTIS SA - EXPECT TO SUBMIT REQUESTED INFORMATION RELATED TO MELANI-01 TRIAL TO FDA INCLUDING AMENDED PROTOCOL IN DUE COURSE Source text for Eikon: Further company coverage: (Reuters.Briefs@thomsonreuters.com)

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