RVX-208 Leads to a 77% Relative Risk Reduction of Major Adverse Cardiovascular Events (MACE) in Patients with Diabetes Mellitus - Applied Clinical Trials

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RVX-208 Leads to a 77% Relative Risk Reduction of Major Adverse Cardiovascular Events (MACE) in Patients with Diabetes Mellitus


RVX-208 Leads to a 77% Relative Risk Reduction of Major Adverse Cardiovascular Events (MACE) in Patients with Diabetes Mellitus

PR Newswire

Presented in 'State of the Art and Featured Research Session' at the 2014 European Society of Cardiology Congress

TSX Exchange Symbol: RVX

BARCELONA, Spain and CALGARY, AB, Sept. 2, 2014 /PRNewswire/ - Resverlogix Corp. (TSX: RVX) announced today that Dr. Jan Johansson, senior vice president of medical affairs at Resverlogix delivered an oral presentation at the 2014 European Society of Cardiology (ESC) Congress in Barcelona, Spain. In his presentation, entitled: ' Effects of RVX-208 on MACE, ApoA-I and HDLs; a post-hoc analysis from the pooled SUSTAIN and ASSURE clinical trials ', Dr. Johansson reported that patients with cardiovascular disease (CVD) arising from atherosclerosis when given RVX-208 had a 55% (p=0.02) relative risk reduction (RRR) in MACE. More importantly, this beneficial effect of RVX-208 on patients with diabetes mellitus was accentuated with a RRR in MACE that was lowered by 77% (p=0.01). These observed reductions in MACE may stem from the ability of RVX-208 to significantly improve specific biomarkers of CVD risk measured in the SUSTAIN and ASSURE trials, including: higher levels of ApoA-I protein (p<0.01), an increase in HDL-C (p<0.001), more large HDL-particles (p<0.05) and growth in HDL particle size (p<0.05). The significant improvement in these biomarkers was in treated patients vs. placebo, which point to the beneficial effects of RVX-208 on reverse cholesterol transport.

RVX-208 acts via an epigenetic pathway and it is the first selective BET inhibitor being studied for treatment of CVD. The new information contained in the ESC presentation arose from the analysis of data pooled from the ASSURE and SUSTAIN clinical trials.

"The above findings are valuable to Resverlogix because they put the company in an advantageous position in the emerging field of therapeutics based on BET inhibition," said Dr. Norman C.W. Wong, chief scientific officer of Resverlogix and also a practicing endocrinologist. "The data enhances the potential for RVX-208 to lower MACE in CVD patients and especially in those with diabetes mellitus. These key pieces of information will be used for the design of our next clinical trial that will continue the development of RVX-208 towards product registration."

Donald McCaffrey, president and chief executive officer of Resverlogix added, "We are very pleased to have this data highlighted at the ESC Congress. It underscores our plans to diversify the development of RVX-208 by studying its activity in additional indications. Moving forward, in addition to the clinical paths in cardiovascular disease, diabetes mellitus and Alzheimer's Disease, we are exploring other indications pertaining to chronic kidney disease (CKD), nonalcoholic steatohepatitis (NASH) and human immunodeficiency virus (HIV) lipodystrophy."

About RVX-208

RVX-208 is a first-in-class small molecule that selectively inhibits BET bromodomains. RVX-208 functions via several mechanisms such as removing atherosclerotic plaque via reverse cholesterol transport (RCT), the natural process through which atherosclerotic plaque is transported out of the arteries and then removed from the body by the liver. RVX-208 increases production of Apolipoprotein A-I (ApoA-I), the key building block of functional high-density lipoprotein (HDL) particles and the type required for RCT. These newly produced, functional HDL particles are flat and empty and can efficiently remove plaque and stabilize or reverse atherosclerotic disease. Analysis of recent clinical trials data showed that RVX-208 significantly reduces coronary atherosclerosis and major adverse cardiac events in patients with CVD who have a low level of HDL and elevated hsCRP, a population with unmet medical need. ApoA-I enhancement and glucose lowering have been reported to exert beneficial effects in Alzheimer's disease and diabetes mellitus, respectively. RVX-208 also has anti-inflammatory effects including effects on Interleukin-6 inhibition, vascular cell adhesion-1 and monocyte chemotactic protein-1, factors known to be involved in atherosclerosis and plaque stability.

About Resverlogix

Resverlogix Corp. (TSX: RVX) is a clinical stage cardiovascular company developing compounds involving a therapeutic increase in ApoA-I. RVX-208 is a first-in-class small molecule for the treatment of atherosclerosis and other chronic diseases such as Diabetes Mellitus and Alzheimer's disease. RVX-208 is the first 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.

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.

Company Contacts:          
           
Donald J. McCaffrey            Kenneth Lebioda
President and CEO             SVP Business & Corporate Development
Resverlogix Corp.            Resverlogix Corp.
Phone: 403-254-9252            Phone: 403-254-9252
Email: don@resverlogix.com           Email: ken@resverlogix.com
 
Media:
 
Matt Middleman, M.D.
Russo Partners, LLC
Phone: 212-845-4272
Email: matt.middleman@russopartnersllc.com

 

SOURCE Resverlogix Corp.

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