First patient randomized in BETonMACE Phase 3 trial in high-risk coronary artery disease and type 2 diabetes mellitus patients
CALGARY, Nov. 11, 2015 /CNW/ - Resverlogix Corp. (the "Corporation") (TSX:RVX) today announced that the first patient has been randomized and dosing has commenced in the Phase 3 clinical trial 'BETonMACE' with lead drug apabetalone (RVX-208) in high-risk patients with coronary artery disease (CAD) and type 2 diabetes mellitus (DM). The primary outcome measure will assess the effect of apabetalone on time to first occurrence of Major Adverse Cardiovascular Events (MACE) in high-risk type 2 DM patients with CAD. In the primary outcome measure, MACE is narrowly defined as a single composite endpoint of cardiovascular death, or non-fatal myocardial infarction (MI), or stroke. All subjects will remain on a high-dose statin therapy (atorvastatin or rosuvastatin), with the experimental group receiving 200 mg/day of apabetalone in the form of 100 mg capsules twice daily. Additional trial details and updates can be found at: www.clinicaltrials.gov and/or www.clinicaltrialsregister.eu/.
Dr. Michael Sweeney, senior vice president of clinical development stated, "We are pleased to announce that dosing has commenced in BETonMACE only two weeks after of the opening of our first sites. Every team member has worked exceptionally hard to expedite the process with rigorous attention to detail."
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 diseases such as high-risk cardiovascular disease (CVD), diabetes mellitus (DM), chronic kidney disease, Alzheimer's disease, 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, currently in a Phase 3 trial BETonMACE in high-risk CVD patients with type 2 DM and low high-density lipoprotein (HDL). Resverlogix's common shares trade on the Toronto Stock Exchange (TSX: RVX). For further information please visit www.resverlogix.com. We can be followed on our blog at http://www.resverlogix.com/blog and via Twitter @Resverlogix_RVX https://twitter.com/resverlogix_rvx.
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, Alzheimer's disease, Orphan diseases, and peripheral artery disease. 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.
For further information, please contact:
Donald J. McCaffrey
President and CEO
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Director of Investor Relations & Corporate Communications
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SOURCE Resverlogix Corp.