IMI announces major clinical trial with ColorectAlert(TM)
July 05 2005 - 5:30PM
PR Newswire (US)
IMI announces major clinical trial with ColorectAlert(TM) -
Sponsored by U.S. National Cancer Institute's EDRN - Patented
painless, low-cost technology shows promise as screening tool for
early-stage colorectal cancer TORONTO, July 5
/PRNewswire-FirstCall/ -- IMI International Medical Innovations
Inc. (Amex: IME; TSX:IMI) today announced a collaborative research
agreement with members of the U.S. National Cancer Institute's
(NCI) Early Detection Research Network's (EDRN) Great Lakes-New
England Clinical Epidemiology Center Consortium (GLNE CEC
Consortium) to include IMI's ColorectAlert(TM) test in a major
colorectal cancer clinical trial. The EDRN, funded by the NCI,
focuses on the development, testing and evaluation of promising
biomarkers or technologies for the early detection of cancer. "This
600-patient study is expected to support ColorectAlert(TM)'s
effectiveness as a tool for the early detection of colorectal
cancer," said Dr. Brent Norton, President and Chief Executive
Officer, IMI. "The EDRN study follows other strategic milestones in
our business, including the start of commercialization of our first
cardiovascular product, PREVU(x) Point of Care (POC) Skin Sterol
Test, the initiation of a pivotal study for our breast cancer test
and the launch of a key PREVU(x) study in the insurance industry."
Dr. Norton continued, "Having the NCI co-sponsor and the EDRN's
GLNE CEC Consortium lead this trial is very exciting. Our test is
targeted for use in large-scale screening programs because it is
simple, painless and inexpensive. Undertaking this study fits with
our strategy aimed at making ColorectAlert(TM) a clinical and
commercial success." "Early-stage colorectal cancers are the most
difficult to detect because patients often do not have any symptoms
--- but when colorectal cancer is detected early it is curable more
than 90% of the time," said Dr. Dean Brenner, lead investigator of
the trial, who is a professor at the University of Michigan and
principal investigator of the EDRN's gastrointestinal research
group. "Early detection of colorectal cancer is a top priority
given the high cost of treatment and the high mortality rate
associated with this disease. With this trial, we hope to validate
markers that will help to improve upon the specificity and
sensitivity of fecal occult blood tests (FOBTs), which is currently
the most frequently used screening method for colorectal cancer."
Details of the trial include: - ColorectAlert(TM) will be included
in a 600-patient, multi-center, prospective cross-sectional cohort
validation trial examining FOBT, stool genetic tests and other
markers for colorectal cancer. - The NCI is a sponsor of this
study, which is the first validation trial conducted by the EDRN,
along with other industrial co-sponsors. - The trial, which will be
conducted at various sites, is to be led by the GLNE CEC
Consortium, which consists of the University of Michigan, the Dana
Farber Cancer Institute, Dartmouth Medical School and St. Michael's
Hospital in Toronto, Ontario. The University of Texas M.D. Anderson
Cancer Center will also participate. The clinical trial will
include three categories of patients: those diagnosed with cancer,
those with polyps and those with no disease. The study will examine
the ability of multiple markers to identify the presence of cancer
alone and in combination. Patients will be tested at baseline and
then following treatment in cases where treatment is required.
About ColorectAlert(TM) The patented ColorectAlert(TM) test is
performed on a sample of rectal mucus taken by a digital rectal
exam during a routine doctor visit. The sample is sent to a lab
where it is treated with a series of chemicals that produce a
color-change reaction identifying a cancer-associated sugar. The
color change is read by a spectrophotometer to provide a numeric
result. Previous studies on 2,000 patients have demonstrated that
higher ColorectAlert(TM) values are associated with greater
incidence of colorectal cancer. About Colorectal Cancer Colorectal
cancer is the third most prevalent cancer in North America, with
164,890 new cases and 64,690 deaths expected in 2005. Colorectal
cancer is the second leading cause of cancer deaths overall.
Colorectal cancer begins as a benign polyp that subsequently
evolves into a malignant lesion. The cancer becomes invasive when
it penetrates the wall of the colon or rectum. The relatively high
mortality rate is due in part to the lack of accurate screening
tests for the early detection of the disease. However, more than
90% of colorectal cancer cases are curable when detected early. The
primary risk factor for colorectal cancer is age, with more than
90% of cases diagnosed in individuals over the age of 50. Screening
every two years is recommended for all people over the age of 50.
(Sources: American Cancer Society; Canadian Cancer Society) About
IMI IMI (http://www.imimedical.com/) 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, are 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 information regarding PREVU(x), please go visit
http://www.prevu.com/. Corporate Name Change In September 2005, IMI
will change its corporate name to PreMD Inc. to better reflect the
company's leading position in the predictive medicine field. The
new website will be 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 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, the inability of
the Company to change its name to PreMD Inc. in the time projected
due to any reason, 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 and Media Contacts: Andrea Faville, Sally Martin, The
Investor Relations Group, T: (212) 825-3210, ,
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