Resverlogix Announces Full Enrollment of SUSTAIN, a Phase 2b Clinical Trial Targeting High-Risk Cardiovascular Disease Patients
TSX Exchange Symbol: RVX
CALGARY, Nov. 28, 2011 /PRNewswire/ - Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) today announced that SUSTAIN, a Phase 2b clinical trial comprised of 176 subjects, is fully enrolled. The Cleveland Clinic leads this trial in which all subjects have established atherosclerotic cardiovascular disease (CVD) and low high-density cholesterol (HDL-C). In SUSTAIN, all subjects will receive standard of care therapy that includes up to 40 mg atorvastatin (Lipitor) or 20 mg rosuvastatin (Crestor). Despite the standard of care therapy in the SUSTAIN population, the risk of recurrent CVD events remains exceedingly high. Thus this patient population presents an ideal opportunity to test the effects of placebo vs. RVX-208 (200 mg/day) an orally active small molecule that raises ApoA-I production and thereby increases HDL-C. SUSTAIN is a 24-week, multi-center, double-blind, randomized, parallel group, placebo controlled clinical trial to assess lipid trends and safety of RVX-208. Additionally, other biomarkers of reverse cholesterol transport (RCT) will be examined. The primary endpoint of SUSTAIN is the change in HDL-C from baseline after receiving RVX-208 for 24 weeks vs. placebo. Secondary endpoints include change in ApoA-I, LDL-C, non-HDL-C, apoB, TG and HDL subclasses. Resverlogix expects top line data by late 2012.
"The speed of patient enrollment for SUSTAIN has exceeded our expectations," stated Donald McCaffrey, President and Chief Executive Officer of Resverlogix. "The important goals in SUSTAIN are to show safety and lipid altering effects of RVX-208 in subjects with atherosclerotic CVD and low HDL-C given standard of care therapies. Results from SUSTAIN will help to identify a patient population that will likely benefit the most from the actions of RVX-208 on atherosclerotic CVD", Mr. McCaffrey further commented.
RVX-208 is a novel small molecule that stimulates endogenous ApoA-I production to trigger the synthesis of HDL. The use of this approach will enhance the functionality of HDL. ApoA-I is the major protein component of HDL. The main role of these particles is to act as the body's natural defense system against atherosclerosis by mediating a normal physiologic process called reverse cholesterol transport (RCT). This pathway enables cholesterol, including that within atherosclerotic plaques of vessel walls, to be transported to the liver for further processing and elimination from the body. Enhanced RCT clearance of cholesterol from vessel walls should reduce or prevent atherosclerosis. The ability of RVX-208 to increase ApoA-I production and thereby augment RCT differentiates it from other HDL therapies. RVX-208 is positioned to be one of the most promising drugs in development for the treatment of atherosclerosis.
About Resverlogix Corp.
Resverlogix Corp. is a leading biotechnology company engaged in the development of novel therapies for important global medical markets with significant unmet medical needs. The NexVas™ Plaque Regression program is the Company's primary focus which is to develop novel small molecules that enhance ApoA-I production. These vital therapies are focused to address the burden of atherosclerosis and other important diseases such as Acute Coronary Syndrome, Alzheimer's disease, Peripheral Artery Disease and Autoimmune diseases. Resverlogix Corp.'s common shares trade on the Toronto Stock Exchange (TSX:RVX). For further information please visit www.resverlogix.com.
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, the conduct of the SUSTAIN trial 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 & CEO
Director, Investor Relations
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S.A. Noonan Communications, LLC
VP Public Relations
SOURCE Resverlogix Corp.