ASSERT study shows increased transport of Amyloid Beta 40
TSX Exchange Symbol: RVX
CALGARY, Jan. 25 /CNW/ - 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 (Aβ40). This analysis was performed based on increasing evidence in the
literature that the transport of potentially harmful Aβ40 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 Aβ40 is a risk factor for developing Alzheimer's Disease in older patients.
Since the Alzheimer's Disease biomarker Aβ40 bind to ApoA-I it has been hypothesized that increasing ApoA-I would
transport Aβ40 out of the brain thereby decreasing the Aβ40 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 Aβ40 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 Aβ40 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 Aβ40 transport from the brain.
Dr. Jan Johansson Senior Vice President of Medical Affairs stated, "We
have been building upon a hypothesis that increased Aβ40 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 Aβ40 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
(Aβ40) 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 Aβ40 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™ 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 (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
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
SOURCE Resverlogix Corp.
For further information:
Kenneth E. Lebioda
Senior Vice President
|US Institutional Investors|
S.A. Noonan Communications, LLC