Resverlogix ASSERT Trial Data Illustrates Potential for RVX-208 in Alzheimer's Disease
CALGARY, Alberta,
January 25, 2011/PRNewswire/ --
- ASSERT Study Shows
Increased Transport of Amyloid Beta 40
- TSX Exchange
Symbol: RVX
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.
About RVX-208
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 (TSX:RVX). 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
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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.
%SEDAR:
00019253E
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
Website:
http://www.resverlogix.com
Source: Resverlogix Corp.
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
Posted: January 2011
