Resverlogix Completes Dosing in Assure Clinical Trial
CALGARY, Alberta, April 18, 2013 /PRNewswire/ --
IVUS data will evaluate plaque regression in patients with high-risk Cardiovascular Disease
TSX Exchange Symbol: RVX
Resverlogix Corp. (TSX:RVX) today announced that it has completed dosing in ASSURE, a Phase 2b clinical trial evaluating RVX-208, Resverlogix's first-in-class orally active BET-protein inhibitor, using intra-vascular ultrasound (IVUS) in high-risk cardiovascular patients with low HDL and ApoA-I (n=324). These target patients have significant residual risk in major adverse coronary events (MACE) such as heart attack, unstable angina, stroke, revascularization and death, despite standard of care therapy such as statins. The main underlying cause of the residual risk in these patients is atherosclerosis. ASSURE is designed to evaluate the ability of RVX-208 to regress atherosclerotic disease.
"Atherosclerosis regression represents a new paradigm in the treatment of high-risk cardiovascular disease patients," said Donald McCaffrey, president and chief executive officer of Resverlogix. "The completion of the ASSURE trial is a major development milestone for the company. RVX-208 is the first small molecule BET inhibitor that raises the production of ApoA-I to be tested in a landmark IVUS trial."
ASSURE is a 26-week, multi-center, double-blind, randomized, parallel group, placebo-controlled trial led by the Cleveland Clinic. To assess atherosclerosis regression in ASSURE, all subjects were examined using IVUS. The primary endpoint in ASSURE is to detect a change in percent atheroma volume as determined by IVUS at baseline vs. 26 weeks of treatment. The use of IVUS technology will provide details regarding plaque composition and stability, which is important because both are elements leading to acute coronary syndrome. Secondary endpoints for
ASSURE include safety and tolerability of RVX-208, effects of the compound on plasma ApoA-I, HDL-C, HDL-subclasses and non-HDL lipid
parameters such as the CRP inflammation marker. Top line data is expected mid-2013.
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.
Resverlogix Corp. (TSX: RVX) is a clinical stage cardiovascular company with an epigenetic platform technology that modulates protein production. Resverlogix is developing RVX-208, a first-in-class small molecule for the treatment of atherosclerosis. RVX-208 is the first BET bromodomain inhibitor in clinical trials. This drug also has the potential to treat other indications, including diabetes mellitus, and neurodegenerative disorders. New compounds arising from Resverlogix's epigenetic drug discovery platform function by inhibiting BET bromodomains and have the potential to impact multiple therapeutic indications including cancer and autoimmune diseases. Resverlogix's common shares trade on the Toronto Stock Exchange (TSX: RVX). For further information please visit http://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 http://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
US Institutional Investors:
S.A. Noonan Communications, LLC
Director of Investor Relations
Matt Middleman, M.D.
Russo Partners, LLC
Posted: April 2013