IMI provides update on ARISE clinical trial
February 28 2005 - 8:00AM
PR Newswire (US)
IMI provides update on ARISE clinical trial TORONTO, Feb. 28
/PRNewswire-FirstCall/ -- Amendments approved last week by the U.S.
Food and Drug Administration (FDA) to accelerate AtheroGenics,
Inc.'s ARISE clinical trial and increase patient enrollment will
provide IMI International Medical Innovations Inc. (TSX:IMI; Amex:
IME) with valuable new data on skin sterol and its relationship to
primary events such as heart attacks and stroke sooner than
expected, IMI announced today. "We expect ARISE to provide some of
the most exciting data ever collected on skin sterol testing and
early detection of heart disease," said Dr. Brent Norton, President
and Chief Executive Officer. "Previous studies have demonstrated
that skin sterol correlates with the presence and extent of
coronary artery disease and prior heart attack. With data from
ARISE, we may find that skin sterol correlates with primary cardiac
events, such as heart attack, or death. It may also prove to be an
effective tool to monitor patients' response to AtheroGenics, Inc's
novel therapy, AGI-1067." The amendments to ARISE will accelerate
the study and enable IMI to enroll additional patients for testing
with PREVU(x) Point of Care Skin Sterol Test. It will also further
broaden the profile of PREVU(x) POC with leading cardiologists and
cardiac centers in the United States and Canada. The ARISE study is
expected to be completed in the first quarter of 2006. "IMI is
building solid momentum with data that demonstrates a relationship
between skin sterol and primary events," said Dr. Norton. "We
believe that skin sterol testing ultimately has the potential to
save countless lives by predicting - and preventing - heart attacks
before they happen." About PREVU(x) PREVU(x) Point of Care Skin
Sterol Test, which does not require fasting or the drawing of
blood, tests the amount of sterol, or skin tissue cholesterol.
Clinical studies have shown that as cholesterol accumulates on
artery walls it also accumulates in other tissues, including the
skin. High levels of skin sterol are correlated with higher
incidence of coronary artery disease (CAD). PREVU(x) POC is
currently being commercialized in the United States, Canada and
Europe where it will be made available as a point-of-care test.
PREVU(x) POC is marketed and distributed worldwide by McNeil
Consumer Healthcare, Canada. About IMI IMI is a world leader in
predictive medicine, dedicated to developing rapid, non-invasive
tests for the early detection of life-threatening diseases. IMI's
cardiovascular products, which are branded as PREVU(x) Skin Sterol
Test, will be marketed and distributed worldwide by McNeil Consumer
Healthcare, Canada. The company's cancer tests include
ColorectAlert(TM), LungAlert(TM) and a breast cancer test. IMI's
head office is located in Toronto, and its research and product
development facility is at McMaster University in Hamilton,
Ontario. For further information, please visit
http://www.imimedical.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 lack of operating profit and availability of
funds and resources to pursue R&D projects, the successful and
timely completion of clinical studies, the successful development
or marketing of the Company's products, reliance on third-party
manufacturers, the competitiveness of the Company's products if
successfully commercialized, 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. IMI
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: IMI
International Medical Innovations Inc. CONTACT: Company Contact:
Sarah Borg-Olivier, Director, Communications, T: (416) 222-3449, ;
U.S. Investor Contact: Andrea Faville, The Investor Relations
Group, T: (212) 825-3210,
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