Imi Medical Innovations (AMEX:IME)
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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, ,