Epigenetics Trial:
CALGARY, Alberta, June 12, 2019 (GLOBE NEWSWIRE) -- Resverlogix Corp. (“Resverlogix” or the "Company") (TSX:RVX) is pleased to announce today that all patients active in BETonMACE, the Company’s event-based, phase 3 registration trial, recently completed their last study visits on treatment. Final, follow-up safety visits are progressing and are expected to be completed by July 4th, 2019. Once safety visits have concluded for all patients, Resverlogix anticipates being in a position to provide an updated projected timeframe for top-line data readout.
The remaining steps are amongst those required to assure an orderly, safe and efficient culmination of BETonMACE:
•Three to four weeks after the last study visit for each patient, a follow-up safety visit will take place either in-person or via phone call to ensure that any safety issues continue to be monitored
•In parallel, the third-party adjudication committee will continue to adjudicate remaining and ongoing potential MACE events ◦Additional MACE (over 250) that accumulate during this period will be added to the results while not slowing down the trial’s move towards final database lock
•All patients who have discontinued the study will be contacted for an unscheduled follow-up visit or call to determine medical status
•Database Lock (DBL) will occur sometime after the last patient’s final visit and the last query is resolved
•Approximately two weeks after DBL, the primary endpoint and additional secondary and exploratory endpoints are expected to be announced
•Late-2019 and beyond – full outcomes, pre-specified endpoint data, safety results, and clinical implications are expected to be reported and published
Quelle:
web.tmxmoney.com/...newsid=7452337584543414&qm_symbol=RVX
