Resverlogix Completes Enrollment in ASSURE Trial
Alberta (ots/PRNewswire)
IVUS data will evaluate plaque regression in patients with Coronary Artery Disease
TSX Exchange Symbol: RVX
Resverlogix Corp. today announced that it has completed enrollment in ASSURE, a Phase 2b clinical trial targeting high-risk cardiovascular disease patients. ASSURE will evaluate the ability of RVX-208, Resverlogix's BET protein inhibitor, to regress atherosclerotic disease versus placebo using intravascular ultrasound (IVUS) technology in patients with coronary artery disease (CAD).
"Completing enrollment of the ASSURE clinical trial marks another major milestone for Resverlogix as we aim to demonstrate the efficacy of RVX-208 in atherosclerotic plague regression," stated Donald McCaffrey, president and chief executive officer of Resverlogix. "RVX-208 stimulates production of ApoA-I, increasing the functional HDL particles required for reverse cholesterol transport. We expect to announce top-line data from ASSURE in H1 2013."
ASSURE is a 26-week, multi-center, double-blind, randomized, parallel group, placebo-controlled clinical trial led by the Cleveland Clinic. The primary trial endpoint will be measurement of atheroma volume reduction from baseline to 26 weeks measured by IVUS. Secondary objectives for ASSURE are evaluating the safety and tolerability of RVX-208 and effects of RVX-208 on HDL and non-HDL lipid parameters. Using IVUS data, we will also assess changes in plaque stability, an important factor affecting risk of myocardial infarction.
About RVX-208
RVX-208 is a first-in-class, small molecule that inhibits BET bromodomains. It is currently in clinical study for the treatment of atherosclerosis. 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 ApoA-I, the key building block of functional high-density lipoprotein (HDL) particles and the type required for RCT. Because they are newly produced, these functional HDL particles are flat and empty and can efficiently remove plaque and stabilize or reverse atherosclerotic disease. RVX-208 is currently being evaluated in phase 2b studies for its ability to reverse and/or stabilize atherosclerotic disease. The drug candidate also has the potential to treat other indications, including neurodegenerative disorders.
About Resverlogix
Resverlogix Corp. 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. New compounds arising from Resverlogix's epigenetic drug discovery platform function by inhibiting BET bromodomains and have the potential to impact multiple diseases including cancer, autoimmune and neurodegenerative disorders. Resverlogix's common shares trade on the Toronto Stock Exchange . For further information please visit http://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 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:
Company Contacts:
Donald J. McCaffrey President and CEO Resverlogix Corp. Phone: +1-403-254-9252 e-mail: don@resverlogix.com
US Institutional Investors:
Susan Noonan Managing Partner S.A. Noonan Communications, LLC Phone: +1-212-966-3650 e-mail: susan@sanoonan.com
Sarah Zapotichny Director of Investor Relations Resverlogix Corp. Phone: +1-403-254-9252 e-mail: sarah@resverlogix.com
Media:
Matt Middleman, M.D. Russo Partners, LLC Phone: +1-212-845-4272 e-mail: matt.middleman@russopartnersllc.com