Skin Cholesterol Linked To Cardiovascular Disease Risk In Asymptomatic Individuals
05 Novembro 2007 - 12:30PM
PR Newswire (US)
PASA Data Presented at American Heart Association TORONTO, Nov. 5
/PRNewswire-FirstCall/ -- PreMD Inc. (TSX:PMD;AMEX:PME) announced
that the company's novel non-invasive skin cholesterol test has
demonstrated the ability to detect risk of cardiovascular disease
in asymptomatic subjects, according to new data being presented
this morning at the Annual Scientific Sessions of the American
Heart Association in Orlando, Florida. This study marks the largest
clinical trial to date to evaluate levels of skin cholesterol in
asymptomatic individuals. Entitled -"Increased Skin Cholesterol
Identifies Individuals at Increased Cardiovascular Risk: The
Predictor of Advanced Subclinical Atherosclerosis (PASA) Study,"
the study supports the usefulness of non-invasive skin cholesterol
measurements for cardiovascular disease risk assessment. Results of
the PASA Study showed that skin cholesterol content, measured by
PreMD's skin cholesterol test, was associated with carotid
intima-media thickness (CIMT) and the presence of carotid plaque.
This association was observed in subjects across all ranges of
cardiovascular risk, particularly in those at low and intermediate
risk, based on traditional cardiovascular risk factors. CIMT and
carotid plaque are both well-established markers for risk of future
heart attack and stroke. "Because skin cholesterol content can
non-invasively identify individuals with advanced subclinical
atherosclerosis, it may become an important office-based tool for
cardiovascular risk prediction," said lead investigator, James H.
Stein, MD, Associate Professor of Medicine, Division of
Cardiovascular Medicine, University of Wisconsin School of Medicine
and Public Health. "These study results show that even low and
intermediate risk subjects with elevated skin cholesterol are at
increased risk of cardiovascular disease," said Dr. Brent Norton,
president and chief executive officer of PreMD. "These very
important data supports the utility of our skin cholesterol test as
part of cardiovascular risk assessment for asymptomatic subjects.
We anticipate that these findings will help us obtain broader
clearance with the U.S. Food and Drug Administration (FDA) on our
skin cholesterol test." "Refining cardiovascular risk assessment
remains a challenging task, especially because most advances are
based on expensive imaging technologies or sophisticated blood
testing," said G. B. John Mancini, MD, FRCPC, FACC, Professor of
Medicine, Division of Cardiology, University of British Columbia.
"This study shows that the skin cholesterol measurement is
independently associated with subclinical atherosclerosis. This is
extremely exciting news because the methodology is simple,
completely non-invasive and practical for widespread use." PreMD's
skin cholesterol test non-invasively measures the amount of
cholesterol that has accumulated in the skin tissues. There is no
fasting or other patient preparation required for the test.
Clinical studies have demonstrated an association between
cholesterol accumulation on artery walls and its accumulation in
skin. High levels of skin cholesterol are correlated with higher
incidence of coronary artery disease (CAD). PreMD's skin
cholesterol test is cleared for sale in Canada and Europe but not
yet cleared for use in asymptomatic subjects in the U.S., which is
currently pending review by the FDA. On July 16, 2007, the company
signed an agreement with AstraZeneca Pharmaceuticals LP for the
marketing and distribution of the skin cholesterol test in the
United States. Results of the PASA Study The study, conducted at
six sites in North America (University of Wisconsin School of
Medicine and Public Health; University of Pennsylvania School of
Medicine; University of Chicago Pritzker School of Medicine;
University of Minnesota School of Public Health and Minneapolis
Heart Institute Foundation; John Hopkins University School of
Medicine; and Radiant Research) included 565 asymptomatic
individuals. Patients underwent B-mode ultrasonography of the
carotid arteries to measure CIMT and carotid plaque, and had skin
cholesterol content measured using PreMD's skin cholesterol test.
Skin cholesterol was associated with increased risk of having
increased CIMT and the presence of carotid plaque, two markers of
subclinical atherosclerosis. The relationship between skin
cholesterol and these markers of subclinical atherosclerosis was
observed across all levels of cardiovascular disease risk and was
strongest in subjects at low and intermediate risk based on
traditional risk factors. These findings support the potential
usefulness of non-invasive skin cholesterol measurements as part of
cardiovascular disease risk assessment. About PreMD Inc. PreMD Inc.
is a leader in predictive medicine, dedicated to developing rapid,
non-invasive tests for the early detection of life-threatening
diseases. PreMD's cardiovascular products include a line of
non-invasive skin cholesterol tests, planned to be marketed and
distributed by AstraZeneca Pharmaceuticals. PreMD's other skin
cholesterol products include PREVU(x) LT, a skin cholesterol test
designed for use in the life insurance industry. The company's
cancer tests include ColorectAlert(TM), LungAlert(TM) and a breast
cancer test. PreMD's head office is located in Toronto, Ontario and
its research and product development facility is at McMaster
University in Hamilton, Ontario. For more information about PreMD,
please visit http://www.premdinc.com/. This press release contains
forward-looking statements. These statements involve known and
unknown risks and uncertainties, which could cause the Company's
actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include,
among others, the success of a plan for regaining compliance with
certain continued listing standards of the American Stock Exchange,
successful development or marketing of the Company's products, the
competitiveness of the Company's products if successfully
commercialized, the lack of operating profit and availability of
funds and resources to pursue R&D projects, the successful and
timely completion of clinical studies, product liability, reliance
on third-party manufacturers, the ability of the Company to take
advantage of business opportunities, uncertainties related to the
regulatory process, and general changes in economic conditions. In
addition, while the Company routinely obtains patents for its
products and technology, the protection offered by the Company's
patents and patent applications may be challenged, invalidated or
circumvented by our competitors and there can be no guarantee of
our ability to obtain or maintain patent protection for our
products or product candidates. Investors should consult the
Company's quarterly and annual filings with the Canadian and U.S.
securities commissions for additional information on risks and
uncertainties relating to the forward-looking statements. Investors
are cautioned not to rely on these forward-looking statements.
PreMD is providing this information as of the date of this press
release and does not undertake any obligation to update any
forward-looking statements contained in this press release as a
result of new information, future events or otherwise. DATASOURCE:
PreMD Inc. CONTACT: Brent Norton, President and CEO, PreMD Inc, T:
(416) 222-3449, ; Michelle Rabba, Manager, Corporate
Communications, PreMD Inc., T: (416) 222-3449,
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