December 18, 2017 / 8:58 AM / a year ago

BRIEF-Selvita Says FDA Allows To Resume Clinical Trial Of SEL24

Dec 18 (Reuters) - Selvita SA:

* SAID ON SATURDAY THE FOOD AND DRUG ADMINISTRATION (FDA) HAS ALLOWED THE COMPANY TO RESUME CLINICAL TRIAL OF SEL24 PHASE I/II, CARRIED OUT IN U.S. WITH PATIENTS SUFFERING FROM ACUTE MYELOID LEUKEMIA

* FDA TEMPORARILY SUSPENDED THE TRIAL AFTER “SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTION”

* FDA DECISION ALLOWS TO CONTINUE SEL24 CLINICAL TRIAL, AFTER CHANGING THE TRIAL’S PROTOCOL, INCLUDING ADJUSTING THE DOSING SCHEDULE TO THE STANDARD 3 + 3, AS RECOMMENDED BY FDA

* MODIFICATION OF THE CLINICAL TRIAL PLAN REQUIRES THE APPROVAL OF THE ETHICS COMMITTEES IN THE INDIVIDUAL RESEARCH CENTERS (INSTITUTIONAL REVIEW BOARD)

* THE COMPANY IS WORKING ON THIS TOGETHER WITH DOCTORS CONDUCTING RESEARCH IN INDIVIDUAL CENTERS AND WITH THE MENARINI GROUP

Source text for Eikon:

Further company coverage: (Gdynia Newsroom)

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