Resverlogix ASSERT Trial Data Illustrates Potential for RVX-208 in Alzheimer's Disease
Geschrieben am 25-01-2011 |
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.
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 . 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.
%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
ots Originaltext: Resverlogix Corp.
Im Internet recherchierbar: http://www.presseportal.de
Contact:
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
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