Resverlogix Announces Combined RVX-208 findings from SUSTAIN & ASSURE Phase 2b Trials
"RVX-208 treated patients have significant lower MACE events in high risk CVD patients"
TSX Exchange Symbol: RVX
CALGARY, Jan. 15, 2014 /PRNewswire/ - Resverlogix Corp. (TSX: RVX) today announced new information arising from its ongoing analysis of data from both the SUSTAIN and ASSURE trials in atherosclerotic patients with high risk for recurrent events. This analysis, performed by an independent firm focuses on the potential benefit of RVX-208, a first in class BET-inhibitor, to impact major adverse cardiac events (MACE) over a short time period of 6 months.
When MACE data (n=499) from both SUSTAIN and ASSURE trials were combined, it demonstrated that treatment with RVX-208 lead to a significant reduction in MACE. RVX-208 treated patients (n=331), had less cumulative events of 6.74% vs. 15.09% (p=0.02) in the placebo treated group (n=168). Furthermore, in patients who had elevated CRP > 2.0mg/dL (n=283) the benefit of RVX-208 treatment of patients (n=179) appeared more striking with a cumulative event rate of 6.42% vs. 20.53% (p=0.007) in the placebo group (n=104).
"Analysis of the ASSURE and SUSTAIN data arising from similar atherosclerotic patients with high risk of recurrent events provides important MACE information," stated Donald McCaffrey President and Chief Executive Officer of Resverlogix. "A reduction in MACE will be a critical factor for registration of RVX-208. This analysis provides important information that RVX-208 when used in high risk atherosclerosis patients improves the most central measurement of all, the reduction of MACE in back to back trials" said Mr. McCaffrey.
"We are very excited to have this independent MACE analyses performed from the combined ASSURE and SUSTAIN trials to assess the RVX-208 impact on death, non-fatal myocardial infarct, hospitalizations from cardiac events and percutaneous invasive procedures or revascularizations," stated Dr. Jan Johansson Senior Vice President of Medical Affairs at Resverlogix. "This early data is valuable to have as it illustrates in a cumulative fashion that RVX-208 has the potential to really impact cardiac events in those patients who are at very high risk," Johansson added.
Major adverse cardiac events or MACE refers to adverse events caused by disease processes generally affecting the coronary arteries. These may include what are termed "hard" events such as deaths that are attributed to coronary artery disease and nonfatal myocardial infarctions but also occasionally "soft" events such as angina or revascularizations for progressive coronary artery disease.
RVX-208 is a first-in-class small molecule that inhibits BET bromodomains. RVX-208 functions by removing atherosclerotic plaque via reverse cholesterol transport (RCT), the natural process through which atherosclerotic plaque is transported out of the arteries and 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 CRP, a population with unmet medical need. ApoA-I may also exert beneficial effects in Alzheimer's disease and Diabetes Mellitus.
Resverlogix Corp. (TSX:RVX) is a clinical stage biotechnology company developing compounds involving ApoA-I production. RVX-208 is a first-in-class small molecule in development for the treatment of diseases such as atherosclerosis, 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.
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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 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||Kenneth Lebioda|
|President and CEO||SVP Business & Corporate Development|
|Resverlogix Corp.||Resverlogix Corp.|
|Phone: 403-254-9252||Phone: 403-254-9252|
|Email: firstname.lastname@example.org||Email: email@example.com|
SOURCE Resverlogix Corp.