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7th POSITIVE ANNOUNCEMENT FROM SAFETY MONTERING BDResverlogix Announces Seventh Positive Recommendation From The Data Safety Monitoring Board For Phase 3 Study of Apabetalone 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 Resverlogix Corp August 07, 2018 07:00 ET CALGARY, Alberta,, Aug. 07, 2018 (GLOBE NEWSWIRE) -- 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 disease (CVD) patients has completed a seventh 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, and will conduct additional periodic reviews. Resverlogix, the clinical steering committee, and all investigators remain blinded to the trial data. "The DSMB has now had the opportunity to review data from all of the target 2,400 patients recruited to the BETonMACE study and have not identified any safety issues. There are now sufficient patients recruited to BETonMACE to yield 250 MACE events and we look forward to study completion," stated Dr. Michael Sweeney, M.D., Senior Vice President of Clinical Development. BETonMACE Apabetalone (see description below) is currently being studied in a Phase 3 trial, BETonMACE, in high-risk CVD patients with type 2 diabetes mellitus and low levels of high-density lipoprotein. The primary endpoint of the BETonMACE trial is designed to establish a relative risk reduction of Major Adverse Cardiac Events, narrowly defined as a single composite endpoint of cardiovascular death, non-fatal myocardial infarction or stroke. In BETonMACE, two additional pre-specified endpoints will be captured, the first being renal function. Approximately 11% of the participants in the study will also have Stage 3 chronic kidney disease, which is defined by an estimated glomerular filtration rate below 60 at baseline. Additionally, pre-specified analysis of cognitive function will take place in approximately 18% of the study participants aged 70 and older. Cognitive function will be assessed using the Montreal Cognitive Analysis (MoCA). This group will be tested in the following categories: those with a baseline MoCA of 26 or above, deemed cognitively normal, and those with a baseline MoCA of 25 or below, defined as those who have some form of cognitive disorder. About Resverlogix Resverlogix 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 a BET inhibitor selective for the second bromodomain (BD2) within the BET proteins. This selective inhibition of apabetalone on BD2 produces a specific set of biological effects with potentially important benefits for patients with high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis, neurodegenerative disease, Fabry disease, peripheral artery disease and other orphan diseases, while maintaining a well described safety profile. Resverlogix common shares trade on the Toronto Stock Exchange (TSX:RVX). Follow us on Twitter: @Resverlogix_RVX For further information please contact: Investor Relations Email: ir@resverlogix.com Phone: 403-254-9252 Or visit our website: www.resv |
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