Resverlogix Completes Dosing of RVX-208 in SUSTAIN, a Phase 2b Clinical Trial Targeting High-Risk Cardiovascular Disease Patients
TSX Exchange Symbol: RVX
CALGARY, May 9, 2012 /PRNewswire/ - Resverlogix Corp. (TSX:RVX) is pleased to announce that dosing in SUSTAIN, a Phase 2b clinical trial to assess lipid trends and safety of RVX-208, has been completed on schedule. All patients in the Cleveland Clinic led trial had significant cardiovascular disease (CVD) risks.
In SUSTAIN, a 24-week, multi-centered, double-blind, randomized, parallel group, placebo controlled trial, all subjects received standard of care therapy including up to 40 mg atorvastatin (Lipitor) or 20 mg rosuvastatin (Crestor). As recently stated, RVX-208 is the first known BET Bromodomain inhibitor to be studied in humans. It is an orally active small molecule that raises ApoA-I production leading to enhanced reverse cholesterol transport (RCT). SUSTAIN trial subjects received either RVX-208 (200 mg/day) or placebo for 24 weeks for the purposes of studying a panel of lipid parameters versus baseline. SUSTAIN is an important component of an expanded clinical program that includes a parallel Phase 2b clinical trial, ASSURE. The ASSURE trial will utilize intravascular ultrasound (IVUS) to study the important atherosclerotic plaque regressing aspects of RCT. The unique mechanism by which RVX-208 can potentially regress atherosclerotic plaque distinguishes it from all other known drug classes or small molecule candidates in clinical development. Resverlogix expects to report top line data for SUSTAIN in Q3 2012 and for ASSURE in Q1 2013.
"We have completed dosing in the SUSTAIN trial, right on schedule," stated Donald McCaffrey, president and chief executive officer of Resverlogix. "Data from this trial will be used to assess the safety and efficacy of RVX-208 in a high-risk population with CVD. This population provides an ideal opportunity to test the effects of RVX-208. We are particularly interested in confirming the safety of RVX-208 in the extended dosing time frame from three to six months."
Allan Gordon, M.D., Ph.D. and senior vice president of clinical development at Resverlogix, added, "the SUSTAIN trial extends the duration of clinical exposure to RVX-208 by 3 months. Not only will this data provide us with important insights into the safety and efficacy of RVX-208, we also expect important new information for the future development of RVX-208."
RVX-208 is a novel small molecule that targets and inhibits BET Bromodomains. It is the first small molecule of this novel class of compounds in clinical development. RVX-208 stimulates endogenous ApoA-I production leading to enhanced reverse cholesterol transport (RCT). The main role of ApoA-I is to assist the body's natural defense system against atherosclerosis as ApoA-I performs its function in a normal physiologic process called 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 to augment RCT is a highly differentiated approach from all other CVD 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 our primary focus which is to develop novel small molecules that enhance ApoA-I production and remove atherosclerotic plaque. 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, Oncology and Autoimmune diseases. Resverlogix' 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.
For further information, please contact:
Donald J. McCaffrey
President and CEO
Director of Investor Relations
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S.A. Noonan Communications, LLC
Tony Russo, Ph.D.
Matt Middleman, M.D.
Russo Partners, LLC
Phone: 212 845 4251
SOURCE Resverlogix Corp.