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Resverlogix ASSERT Trial Data Illustrates Potential for RVX-208 in Alzheimer's Disease
Calgary, Alberta (ots/PRNewswire) - Resverlogix announced today that its lead drug RVX-208, a first in class ApoA-I production drug, illustrated positive effects on an important cognitive function and Alzheimer's Disease (AD) marker, plasma Amyloid beta 40 (Abeta40). This analysis was performed based on increasing evidence in the literature that the transport of potentially harmful Abeta40 from the brain to the general circulatory system may be beneficial.
Several population studies have indicated that high HDL cholesterol is associated with protection from developing Alzheimer's Disease. It has also been shown that low plasma Abeta40 is a risk factor for developing Alzheimer's Disease in older patients. Since the Alzheimer's Disease biomarker Abeta40 bind to ApoA-I it has been hypothesized that increasing ApoA-I would transport Abeta40 out of the brain thereby decreasing the Abeta40 load in the brain, in effect having possible disease modifying effect.
To assess potential for treatment effects by RVX-208 on Alzheimer's Disease, plasma Abeta40 was analyzed before and after 12 weeks treatment in a stable coronary artery disease population, i.e. the ASSERT population of 299 patients.
In the quartile with the lowest plasma Abeta40 at baseline, which is known to be at greater risk for developing Alzheimer's Disease, at a dose of 150 mg, b.i.d., a highly significant 34.8 pg/mL change from baseline (p=0.0013) and 13.4% change compared to placebo was observed. The data further supports previous Phase I trial data and the hypothesis that RVX-208 treatment can also augment Abeta40 transport from the brain.
Dr. Jan Johansson Senior Vice President of Medical Affairs stated, "We have been building upon a hypothesis that increased Abeta40 seen in plasma illustrates movement out of the brain. We believe the augmented ApoA-I production by RVX-208, functional HDL and enhanced reverse cholesterol transport, could be transporting potentially harmful Abeta40 from the brain to plasma. This is a very important new area of neurovascular biology that we intend to pursue."
"These repeated findings will help continue to drive our efforts to further understand the complex relationship between lipoproteins, amyloid beta and the devastating disease of Alzheimer's. Further analysis and planning will take place prior to determining the next steps, however, as this drug has already passed Phase I, of the FDA review process, a future trial would likely commence as a Phase II program in Alzheimer's Disease patients," added Dr. Johansson.
Emerging evidence and data is accumulating for a protective effect of good HDL cholesterol against Alzheimer's Disease. Key findings from large epidemiology studies such as the Harvard Women's Study, the Honolulu Aging Study, the White Hall 2 study and the Manhattan Cognitive Study continue to build the relationship between increased HDL, ApoA-I and improved cognitive function and Alzheimer's outcomes.
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. Apolipoprotein A-I (ApoA-I), the main component of high-density lipoprotein (HDL) represent the body's natural defense system against atherosclerosis by mediating reverse cholesterol transport, i.e. transport of peripheral cholesterol including that of the vessel wall to the liver for processing. Analysis of cognitive biomarkers such as Amyloid Beta 40 (Abeta40) in conjunction with lipid transport markers may also provide new research and development opportunities for RVX-208 in important disease areas such as Alzheimer's Disease. 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) and Abeta40 transport.
RCT is a pathway by which accumulated cholesterol is transported from the arterial wall to the liver for excretion, thus preventing atherosclerosis. Major constituents of RCT include acceptors such as HDL and ApoA-I. A critical part of RCT is cholesterol efflux, in which accumulated cholesterol is removed from macrophages.
The American Heart Association estimates that almost 80 million American Adults have one or more types of cardiovascular disease. CVD remains the number one killer of developed nations. Nearly 2400 Americans die each day from cardiovascular disease.
About ASSERT Trial
The ASSERT study evaluated early biochemical changes in association with increasing doses of an apoA-I inducer (RVX-208 100-300 mg daily) for 12 weeks in statin-treated patients with stable coronary artery disease.
About Vascular Dementia Multi-infarct dementia, also known as vascular dementia, is the second most common form of dementia after Alzheimer's Disease in older adults. Early detection and accurate diagnosis are important, as vascular dementia is at least partially preventable. Vascular dementia is the second most common cause of dementia in the United States and Europe in the elderly, but it is the most common form in some parts of Asia. The prevalence of the illness is 1.5% in Western countries and approximately 2.2% in Japan. It accounts for 50% of all dementias in Japan, 20% to 40% in Europe and 15% in Latin America. The incidence of dementia is 9 times higher in patients who have had a stroke than in controls. 25% of stroke patients develop new-onset dementia within 1 year of their stroke. The relative risk of incident dementia is 5.5% within 4 years of suffering a stroke.
About Alzheimer's Disease
Every 71 seconds, someone in America develops Alzheimer's Disease and it is estimated that by mid-century, someone will develop Alzheimer's every 33 seconds. Neurodegenerative diseases such as Alzheimer's are one of the most debilitating in the developed world with an estimated prevalence in the United States alone to grow to 15 million people by 2050. In a report commissioned by the Alzheimer's Association, caregiver costs in the United States are estimated at US$36.5 billion which includes loss of productivity, absenteeism and worker replacement. In addition it is also estimated that one-half to two-thirds of the cost of AD care stems from unpaid caregivers (often family members), who spend 16-35 hours per week looking after a person with AD. These figures underscore the importance of developing new therapies to aide in the socioeconomic burden of AD.
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 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.'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 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 http://www.sedar.com. Additionally, risks and uncertainties are discussed in detail in the October 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.
For further information:
Kenneth E. Lebioda Senior Vice President Resverlogix Corp. Phone: +1-403-254-9252 Email: Ken@resverlogix.com US Institutional Investors Susan Noonan Managing Partner S.A. Noonan Communications, LLC Phone: +1-212-966-3650 Email: Susan@sanoonan.com
CONTACT: Kenneth E. Lebioda, Senior Vice President, Resverlogix
Corp.,Phone: +1-403-254-9252, Email: Ken@resverlogix.com; US
InstitutionalInvestors, Susan Noonan, Managing Partner, S.A. Noonan
Communications, LLC,Phone: +1-212-966-3650, Email: Susan@sanoonan.com