Resverlogix Presents ASSERT Human Clinical Trial Data at the American Heart Association Late Breaker Session
A second AHA presentation includes mouse model data showing plaque reduction.
TSX Exchange Symbol: RVX
CHICAGO, Nov. 17 /PRNewswire-FirstCall/ - Resverlogix Corp. ("Resverlogix") (TSX:RVX) announces its top line results of the ASSERT Phase 2 clinical trial which will be highlighted at the prestigious American Heart Association Scientific Sessions 2010 Late Breaking Clinical Trial session, by principal investigator Dr. Stephen Nicholls of the Cleveland Clinic. The top line ASSERT trial data was designed to answer questions about how to best proceed with future trial designs for Resverlogix' lead oral small molecule drug RVX-208.
The ASSERT trial data demonstrated that the three key biomarkers in the reverse cholesterol transport (RCT) process showed dose dependant and consistent improvement. The trial showed dose dependent increases in ApoA-l, statistically significant increases in HDL cholesterol including alpha1 particles or functional HDL, and highly statistically significant increases in large HDL particles. RCT is a pathway by which accumulated cholesterol is transported from the arterial wall to the liver for excretion, thus reducing and/or preventing atherosclerosis.
In the high dose, ApoA-I achieved a 5.6% increase with a statistical value of p=0.06. The overall ApoA-I biomarker showed a dose trending statistical significance of p=0.035. Data presented also showed that the ApoA-I and other HDL particles continued to be increasing at the end of the 12 week study. Both the 8.3% HDL cholesterol increase and the 21.1% large particle HDL increase were highly statistically significant, p<0.01 and p<0.001 respectively. These pronounced HDL related increases via ApoA-I production are important as they take place later in the RCT chain of events and strongly indicate plaque regression potential.
"These are very encouraging early findings which suggest the drug (RVX-208) is working in the established patient population that it was designed for, being patients with advanced coronary disease," said Dr. Stephen Nicholls, MBBS, PhD, Medical Director of Intravascular Ultrasound and Angiography Core Laboratories at Cleveland Clinic and Clinical Director of the Cleveland Clinic Center for Cardiovascular Diagnostics and Prevention.
Donald McCaffrey, President and Chief Executive Officer of Resverlogix commented, "The study largely replicates findings previously seen in our earlier 28 day trial, more importantly these findings are now being shown in patients with coronary artery disease on optimal standard of care. The positive changes seen in this trial represent advancement over the current best standard of care available in the USA. We are now well positioned to advance RVX-208 to the next clinical trial having witnessed the substantial and consistent elevation of HDL by ApoA-I production; which strongly indicates that RVX-208 should remove unwanted plaque from the arterial wall which is our main goal."
Resverlogix Senior Vice President of Medical Affairs Dr. Jan Johansson stated, "In patients who received the newer class of statins and had baseline HDL below 45mg/dL, an important high-risk subpopulation, the middle dose of 200 mg saw the most pronounced increases of 12% in ApoA-I (p<0.002), 21% in HDL cholesterol (p<0.015) and 32% in large particle HDL (p<0.018). We are delighted by these results and now have a much better understanding of what doses to use and what patient population to target moving forward in our ASSURE Phase 2b trial."
An additional presentation at the AHA meeting was given by Dr. Norman Wong, Chief Scientific Officer of Resverlogix, containing new data detailing the effects of RVX-208 in vivo. The presentation was titled "RVX-208: An Orally Administrated Small Molecule Reduces Atherosclerosis in ApoE Null Mouse and Raises ApoA-I/HDL in Humans". In the ApoE null mice model of atherosclerosis, the oral administration of RVX-208 reduced aortic plaques in two separate models. The presented model showed plaque reductions of up to 41%.
Resverlogix to Host Webcast on ASSERT Phase 2 Trial Results -
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Resverlogix Corp. will host a live teleconference and webcast today at 2:15 pm Central/1:15 pm Mountain time. The purpose of the teleconference is to discuss the top line results of the Company's Phase 2 clinical trial (ASSERT) for RVX-208. The dial-in numbers for this event are toll free 1-800-319-4610 and international 1-604-638-5340. A link for this webcast will be posted onto the homepage of Resverlogix's website and can be accessed from the following address http://services.choruscall.com/links/resverlogix101117.html .
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-l. 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.
Posted: November 2010