Data Safety Monitoring Board Udpate
posted on
Dec 05, 2016 12:21PM
I am new to this board, but have been following along for a little while now so thanks to all for so many good and useful insights. I thought I would start my first post with some more encouraging news just released.
A data review by the independent Data Safety Monitoring Board resulted in a recommendation for the BETonMACE trial to continue as planned without any modification.
CALGARY, Dec. 5, 2016 /PRNewswire/ - Resverlogix Corp. ("Resverlogix" or the "Company") (RVX.TO) today announced that the independent Data and Safety Monitoring Board (DSMB) for the Company's Phase 3 BETonMACE trial in high-risk cardiovascular disease (CVD) patients has completed a second planned safety review and recommended that the study should continue as planned without any modifications. The DSMB reviewed available study data and noted that no safety or efficacy concerns were identified. The DSMB will conduct additional periodic reviews and will also perform a futility assessment once 125 adjudicated major adverse cardiac events (MACE) have been observed. Resverlogix, the clinical steering committee, and all investigators remain blinded to the actual safety and efficacy results.
"This second review and recommendation of the DSMB to continue as planned in the BETonMACE trial is clearly encouraging. The first patients in the trial have now surpassed the one year mark and apabetalone remains well-tolerated with a consistent safety profile." stated Dr. Michael Sweeney, M.D., Senior Vice President of Clinical Development. "We look forward to reporting additional updates.