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Resverlogix Announces Sixth Positive Recommendation From Data Safety Monitoring Board For Phase 3 Study of Apabetalone
CALGARY, Alberta, Feb. 26, 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 sixth 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 BETonMACE phase 3 trial now has over 2,300 patients enrolled, representing over 95 percent of the approximately 2,400 patients outlined in the study protocol. We are currently considering the extent to which we enroll beyond 2,400 patients to ensure BETonMACE yields 250 MACE events optimally and to include US patients. We now have patients that have been on treatment with apabetalone for nearly 120 weeks, which is nearly five times longer than any treatment duration in any of the Company’s previous Phase 2 trials. Full enrollment continues to be anticipated in the first half of 2018," stated Dr. Michael Sweeney, M.D., Senior Vice President of Clinical Development.
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 the first and only BET inhibitor selective for the second bromodomain (BD2) within the BET protein called BRD4. 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 (CVD), diabetes mellitus (DM), chronic kidney disease (CKD), dialysis, Alzheimer's disease, Fabry disease, other orphan diseases, and peripheral artery disease, while maintaining a well described safety profile. Apabetalone is the only selective BET bromodomain inhibitor in human clinical trials. Apabetalone is currently being studied in a Phase 3 trial, BETonMACE, in high-risk CVD patients with type 2 DM and low high-density lipoprotein (HDL), and is expected to be initiated in a Phase 2a kidney dialysis trial designed to evaluate biomarker changes and safety parameters in up to 30 patients with end-stage renal disease treated with hemodialysis.
Resverlogix common shares trade on the Toronto Stock Exchange (TSX:RVX).
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This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts" and other similar expressions. In particular, this news release includes forward looking information relating to the Company's Phase 3 clinical trial and the potential role of apabetalone in the treatment of CVD, DM, chronic kidney disease, end-stage renal disease treated with hemodialysis, Alzheimer's disease, Fabry disease, and Orphan diseases. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our Annual Information Form and most recent MD&A which are incorporated herein by reference and are available through SEDAR at www.sedar.com. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. The Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.