Increased number of patients and the focus is on patients with greatest medical need
TSX Exchange Symbol: RVX
CALGARY, Sept. 10 /PRNewswire-FirstCall/ - Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announces that the Company's Phase 2 clinical trial, called ASSURE (ApoA-1 Synthesis Stimulation in Acute Coronary Syndrome patients), has made important modifications to the design of the trial which have the potential to demonstrate a more powerful endpoint for the planning of future clinical trials for RVX-208.
Key changes to this clinical trial include: - Raising the number of patients to be recruited from 120 to over 230. - All patients will now undergo an intravascular ultrasound (IVUS) assessment versus the previously planned 60 patients. - Trial sites increase from 20 to approximately 45. - Clinical trials will be conducted in multiple countries to accelerate recruitment. - The study will include patients with low HDL. - Primary endpoint is now plaque regression.
Donald J. McCaffrey, President & CEO of Resverlogix noted, "The most important take away message is that by moving the end point to atherosclerosis regression this will provide a more robust proof of concept. Achieving plaque regression could potentially reduce the development time for RVX-208 by two years."
The planned trial is currently a three month study and dosing is expected to start in 2010. Any changes to the trial will be updated on www.clinicaltrials.gov.
RVX-208, a novel small molecule therapeutic that facilitates endogenous ApoA-1 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(TM) PR program is the Company's primary focus which is to develop novel small molecules that enhance ApoA-1. 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.'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 statements as defined under applicable Canadian securities legislation, including our statements with respect to 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 July 31, 2010 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.
|SOURCE Resverlogix Corp.|
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