Feb 25, 2010
Cleveland Clinic coordinates IVUS testing of RVX-208 in acute coronary syndrome patients
CALGARY, Feb. 25 /CNW/ - Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced today that it has officially activated the first site for the ASSURE 1 trial and commenced enrollment of patients for dosing of RVX-208. ASSURE 1 is the second Resverlogix Phase 2 clinical trial, led by Cleveland Clinic. This trial will examine RVX-208, Resverlogix's oral small molecule therapy for the treatment of atherosclerosis, in patients with acute coronary syndrome (ACS). This preparatory acute coronary syndrome study will ensure that 50 percent of the enrolled patients receive the IVUS (intravascular ultrasound) assessment. The study is chaired by Dr. Steven Nissen, MD, Chairman of the Cleveland Clinic Department of Cardiovascular Medicine and the principal investigator is Dr. Stephen Nicholls, Medical Director of Intravascular Ultrasound at Cleveland Clinic. The Cleveland Clinic has named this trial, ASSURE 1, an acronym for ApoA-l Synthesis Stimulation in Acute Coronary Syndrome patients. The ASSURE 1 study compliments the ongoing ASSERT trial in patients with stable coronary artery disease.
"For the first time Resverlogix anticipates that it will be able to describe early trends for the relationship between RVX-208 and changes in lipid parameters, changes in measures of atheroma burden and plaque composition," said Dr. Jan O. Johansson, M.D., PhD., Senior Vice President Medical Affairs of Resverlogix. Johansson emphasized, "The unmet medical need in coronary atherosclerosis worldwide is huge. The importance of the reduction of atheroma burden via ApoA-l therapies was highlighted in a recent pharmacoeconomic analysis authored by Destum Partners. Destum's research concluded that by using an ApoA-l increasing therapy in patients as a secondary prevention measure, outcomes could be significantly improved and the potential savings to the US health care system, society, and employers beyond current standard of care are from US $22.9 billion and US $76.8 billion annually, for a 1% to 5% regression of atherosclerosis, respectively."
This IVUS study is comprised of 15-20 US sites will dose approximately 120 ACS patients on standard of care therapy and examine lipid effects by RVX-208 compared to placebo control. In half of the patients a change in atherosclerosis will be assessed, i.e. change in plaque volume and plaque composition. The primary objective of this study is to determine the 3 month effect of RVX-208 on change in the plasma levels of ApoA-l in patients with a recent ACS event who require coronary angiography versus placebo. The secondary objectives for this study include assessing the safety and tolerability of the drug through evaluation of adverse events as well as to evaluate the effect of RVX-208 on other lipid parameters.
"There are a number of people who are very pleased that we are able to announce the beginning of our IVUS study. Much planning has been undertaken with our international experts who reside on our IVUS Steering Committee and Clinical Advisory Committee. We are pleased to be able to bring RVX-208 to acute coronary syndrome patients, a group that presents with high cardiovascular risk," said Dr. Allan Gordon, Senior Vice President Clinical Development of Resverlogix Corp.
Resverlogix clinical program is expanding. In unrelated news Resverlogix is pleased to announce today the appointment of Ms. Tina Rarick to the position of Vice President Project Management & Business Operations. Tina recently joined Resverlogix after working for the past six years as a Global Project Manager for Roche Pharmaceuticals. Previous to this Tina was with several pharmaceutical firms including Schering-Plough and SUGEN/Pharmacia. Earlier in her career Tina spent her time in the laboratory as a biologist with Genentech and the University of Utah.
Tina has fifteen years of combined experience working in diverse corporate cultures from start-ups to multinationals. In the last 10 years she has worked in Global Project Management where she was primarily accountable for team leadership, strategic planning and financial management. Some of her key strengths are leading cross-functional internal and partnered global development teams in accomplishing business driven milestones on time and within budget. Tina received her B.S. from the University of Utah and her MBA from Duke University
About RVX-208
RVX-208, a novel small molecule therapeutic that facilitates endogenous ApoA-I production, is positioned to be one of the most promising emerging drugs in the treatment of atherosclerosis. To the Company's knowledge RVX-208 is the only novel small molecule that is specifically designed to increase ApoA-I production and thereby raise HDL levels thus enhancing HDL functionality to augment reverse cholesterol transport (RCT). RCT is a pathway by which accumulated cholesterol is transported from the arterial wall to the liver for excretion, thus preventing 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 PR program is the Company's primary focus which is to develop novel small molecules that enhance ApoA-I. These vital therapies address the burden of atherosclerosis and other important diseases such as Acute Coronary Syndrome, Diabetes, Alzheimer's disease, Peripheral Artery Disease and other vascular disorders. Resverlogix Corp. trades on the Toronto Stock Exchange (TSX:RVX). For further information please visit www.resverlogix.com.
This news release may contain certain forward-looking statements as defined under applicable Canadian securities legislation, including our statements with respect to vision to be a leader in the research, development and commercialization of novel therapeutics that reduce the risk of cardiovascular disease including atherosclerosis, diabetes, Alzheimer's disease, Peripheral Artery Disease and other vascular diseases. These forward-looking statements contained herein 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. 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 known and unknown risks and uncertainties 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 risk factors discussed in other documents we file from time to time with securities authorities, which are available through SEDAR at www.sedar.com. Additionally, risks and uncertainties are discussed in detail in the most recent MD&A. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement 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. The TSX Exchange does not accept responsibility for the adequacy or accuracy of this news release.
%SEDAR: 00019253E