Parallel Phase 2 studies could expedite development timeline
TSX Exchange Symbol: RVX
CALGARY, Oct. 16 /CNW/ - Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) provided an outline yesterday at the Company's Annual General Meeting for shareholders highlighting the Company's clinical plan path for Resverlogix's lead drug, RVX-208, for the treatment of cardiovascular disease.
Resverlogix outlined that the next two clinical studies will be performed in parallel. Start up activities for both studies have already commenced in conjunction with the Cleveland Clinic and the IVUS Steering Committee. The studies, following normal FDA submission guidelines, will include a Phase 2 Pilot Intravascular Ultrasound (IVUS) trial to examine early lipid effects, and atheroma plaque characterization of the coronary vessel wall in 60 acute coronary syndrome patients. In parallel to this, a Phase 2 Dose-Ranging trial will be conducted in 280 stable cardiovascular patients on standard of care therapy, including statins, examining lipid changes. Both of these clinical trials will dose patients with coronary disease who are on standard treatment for 13 weeks. The start-up activities for these trials have commenced with screening, randomization and first dosing expected in Q1 2010. Updates on future clinical trials will be announced as they progress.
"We have made a significant advancement in our clinical trial plans due to the successful results in our most recent Phase 1b/2a clinical trial," said Donald J. McCaffrey, President and CEO of Resverlogix. "We have now been able to initiate Phase 2 Pilot IVUS study activities. For the first time we will now be able to assess RVX-208 effects on actual atherosclerosis plaque within the arterial wall of the heart vessels. We are performing this study in the acute coronary syndrome population which is one of the prioritized patients groups. This is a significant milestone for Resverlogix because it will provide the Company with important coronary plaque data in late 2010. An additional benefit of conducting these two studies in parallel is that we potentially accelerate 2 years of development time, which could enable the product to reach the market sooner," added McCaffrey.
Intravascular ultrasound (IVUS) is an invasive procedure, performed along with cardiac catheterization; a miniature sound probe (transducer) on the tip of a coronary catheter is threaded through the coronary arteries and, using high-frequency sound waves, produces detailed images of the interior walls of the arteries. IVUS is used to view the artery literally from the inside out making it possible for investigators to characterize the plaque and measure the amount of disease present in clinical trial participants.
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(TM) 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 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 on page 22 of the July 31, 2009 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.
For further information: For further information: Theresa Kennedy, VP, Corporate Communications, Resverlogix Corp., Phone: (403) 254-9252, Fax: (403) 256-8495, Email: Theresa@resverlogix.com; Sarah Zapotichny, Manager, Investor Relations, Resverlogix Corp., Phone: (403) 254-9252, Fax: (403) 256-8495, Email: Sarah@resverlogix.com; US Investor Relations: Susan Noonan, Managing Partner, S.A. Noonan Communications, LLC, Phone: (212) 966-3650, Email: firstname.lastname@example.org; US Media Relations: Eric Goldman, Vice President, Rx Communications Group, Phone: (917) 322-2563, Email: email@example.com