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)