TSX Exchange Symbol: RVX
CALGARY, Nov. 2, 2011 /PRNewswire/ - Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced today the commencement of dosing in ASSURE, a Phase 2b clinical trial led by the Cleveland Clinic. ASSURE is a 26-week, multi-center, double-blind, randomized, parallel group, placebo-controlled clinical trial that will assess coronary atherosclerotic plaque changes in response to Resverlogix's lead drug RVX-208 using intravascular ultrasound (IVUS). ASSURE will examine the early effects of RVX-208 induced ApoA-I production on atherosclerotic plaque regression in the setting of patients with coronary artery disease who have a low level of high-density lipoprotein cholesterol (HDL-C). A total of 310 patients are expected to participate in ASSURE of which 77 will receive placebo and 233 will be given 100 mg twice daily of RVX-208.
An IVUS measurement will be taken prior to the first dose of RVX-208 and this will be repeated after 26 weeks of treatment. The primary trial endpoint will be IVUS measurement of a change in percent atheroma volume from baseline to 26 weeks. Secondary objectives for ASSURE are: (i) safety and tolerability of RVX-208 as reflected by adverse events, and (ii) effects of RVX-208 on HDL and non-HDL lipid parameters.
"We are very pleased to have dosed our first patient in the ASSURE clinical trial," stated Donald J. McCaffrey, President & Chief Executive Officer of Resverlogix. "Over the past two weeks we have seen substantial advancements in the enrollment progress for the ASSURE trial. Our initial two sites were activated in late September however most of our 53 regulatory approved sites have come on line in the past week and we expect the remaining 9 sites to be activated this month. The enrollment procedure of ASSURE is to first screen the patients. Should they meet the protocol inclusion criteria, they are then entered into the trial and will be eligible for dosing two weeks after their screen acceptance. We expect screening to proceed forward at a rapid pace, and once all patients have been enrolled we will update the market," McCaffrey added.
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 ASSURE 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.
SOURCE Resverlogix Corp.