RVX-208, the first selective bromodomain extra-terminal (BET) protein inhibitor, significantly reduces alkaline phosphatase (ALP) levels in patients with high vascular risk
TSX Exchange Symbol: RVX
CALGARY, June 1, 2015 /CNW/ - Resverlogix Corp. (TSX: RVX) (the "Company") today announced that new data on RVX-208 was presented at the ERA-EDTA Congress in London, England in a poster entitled: "Effects of RVX-208, a First-in-Class Epigenetic BET-Inhibitor, on Key Renal Parameters in Subjects with a History of CVD, and Chronic Kidney Disease (CKD); a Post-hoc Analysis of Patients from the ASSERT, SUSTAIN and ASSURE Clinical Trials."
Dr. Kam Kalantar-Zadeh, Professor and Chief, Division of Nephrology and Hypertension at University of California in Irvine and Los Angeles stated, "Selective BET inhibition via RVX-208 may represent a novel approach to CKD treatment. Analyses of the data from recent clinical trials suggest that RVX-208 significantly lowers serum alkaline phosphatase (ALP) and improves lipid parameters in patients with CKD. Together these new findings warrant additional clinical trials for target responder CKD and/or dialysis populations who have a high burden of cardiovascular disease and risk." Dr. Kalantar-Zadeh examined the data and contributed to this abstract at ERA-EDTA. He has also contributed to additional abstracts that have been submitted for peer review presentation.
In the pooled analysis from the SUSTAIN and ASSURE trials (n=499), assessment of the metabolic biomarker ALP, revealed a significant reduction of -10.98% in all RVX-208 treated patients (n=331) compared to a reduction of -3.23% in placebo treated patients (n=168) (p<0.0001) at the combined time points of 24 and 26 weeks. In addition, several subgroup analysis were performed. In patients with a history of diabetes, a significant reduction in ALP of -13.9% was observed in the RVX-208 treated group (n=127) compared to -4.49% in the placebo treated group (n=65) (p<0.0001). Further analysis was performed on patients with Chronic Kidney Disease (CKD), defined by an estimated glomerular filtration rate (eGFR) of below 60 mL/min/1.73 m2. In this group, RVX-208 treated patients (n=35) had reduced ALP levels of -13.9% versus -6.28% in placebo (n=13) (p=0.008). In addition, following 6 months of RVX-208 treatment, an increase in eGFR of +3.4% (p=0.04 vs. baseline) in the RVX-208 treated group was observed compared to a decrease of -5.9% in the placebo group.
More information on CKD can be found on our blog at: http://www.resverlogix.com/blog/2015/05/28/resverlogix-our-interest-in-chronic-kidney-disease/ and http://www.resverlogix.com/blog/2015/05/29/resverlogix-further-interest-in-chronic-kidney-disease/.
RVX-208 is a first-in-class, small molecule selective BET bromodomain inhibitor. BET bromodomain inhibition is an epigenetic mechanism that can turn disease-causing genes off, returning them to a healthier state. RVX-208 is the first and only BET inhibitor selective for BRD4-BD2, producing a nexus of biological effects with potentially important benefits for patients with diseases such as cardiovascular disease (CVD), diabetes mellitus (DM), Alzheimer's disease, peripheral artery disease, and chronic kidney disease while maintaining an excellent safety profile. Resverlogix is planning to study RVX-208 in a proposed Phase 3 clinical trial in CVD patients with DM and low HDL.
Resverlogix Corp. is developing RVX-208, a first-in-class, small molecule selective BET bromodomain inhibitor for the potential treatment of patients with cardiovascular disease, diabetes mellitus, Alzheimer's disease, peripheral artery disease, and chronic kidney disease. RVX-208 is the only selective BET bromodomain inhibitor in clinical trials. 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 https://twitter.com/resverlogix_rvx @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 research and development activities and the potential role of RVX-208 in the treatment of atherosclerosis. 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 but not limited to those associated with the success of research and development programs, clinical trial programs including possible delays in patient recruitment, the regulatory approval process, competition, securing and maintaining corporate alliances, market acceptance of the Company's products, the availability of government and insurance reimbursements for the Company's products, the strength of intellectual property, financing capability, the potential dilutive effects of any financing, reliance on subcontractors and key personnel and additional assumptions and risk factors 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.
Donald J. McCaffrey
President and CEO
Senior Vice President Business & Corporate Development
Director of Investor Relations & Corporate Communications
SOURCE Resverlogix Corp.