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Resverlogix Announces Positive Recommendation From Data Safety Monitoring Board For Phase 3 Study of Apabetalone (RVX-208)
Resverlogix Announces Positive Recommendation From Data Safety Monitoring Board For Phase ...
About this update from Resverlogix Corp.
[{"type":"text","content":"\n\n\n\nResverlogix Announces Positive Recommendation From Data Safety Monitoring Board For Phase 3 Study of Apabetalone (RVX-208)\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n\n\n\n\n\n\nResverlogix Announces Positive Recommendation From Data Safety Monitoring Board For Phase 3 Study of Apabetalone (RVX-208)\nCanada NewsWire\nCALGARY, Aug. 11, 2016\n\n\n\nA data review by the independent Data Safety Monitoring Board resulted in a verbal recommendation for the BETonMACE trial to continue as planned without any modification.\n\n\n\nCALGARY, Aug. 11, 2016 /CNW/ - Resverlogix Corp. (\"Resverlogix\" or the \"Company\") (TSX:RVX) today announced that the independent Data and Safety Monitoring Board (DSMB) for the Company's Phase 3 BETonMACE trial in high-risk cardiovascular (CVD) patients has completed a planned safety review and verbally 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.\n\n\"The verbal recommendation of the DSMB to continue as planned in the BETonMACE trial is consistent with the well-established safety profile of apabetalone that has now been demonstrated in over 1,000 patients to date,\" stated Dr. Michael Sweeney, M.D., Senior Vice President of Clinical Development. \"We are encouraged by the recommendation of the DSMB in the BETonMACE study and look forward to reporting additional updates.\" \n\nAbout Resverlogix\n\nResverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. BET bromodomain inhibition is an epigenetic mechanism that can regulate disease-causing genes. Apabetalone is the first and only BET inhibitor selective for the second bromodom...