Category: Uncategorized
November 12, 2002

News Release: Development Progress On Three Cancer-Detection Tests

Predictive medicine company IMI International Medical Innovations Inc. (IMI TSX)reported progress on its development and clinical testing of the Company's three lead cancer-detection tests that are based on the same marker and core technology: ColorectAlert(TM) for colorectal cancer, LungAlert(TM) for lung cancer and a new test for breast cancer.

Upon completion of the analysis of studies involving each of the three cancer tests the Company will publicly release the detailed data to coincide with publication or presentation of the findings to the medical community. ColorectAlert

ColorectAlert is a minimally invasive screening test for colorectal cancer that identifies a cancer-associated sugar in a mucous sample collected at the doctor's office. Unlike the current colorectal cancer screening test (fecal occult blood test - FOBT), ColorectAlert does not require any dietary restrictions by the patient and does not involve handling stool samples. The test is expected to be comparable in cost to FOBT.

In three major studies ColorectAlert has been tested on more than 2,200 samples, including high-risk and low-risk (screening) subjects, and has been compared directly with current standard tests such as FOBT and colonoscopy. The combined results from these studies, led by Dr. Norman Marcon at St. Michael's Hospital in Toronto, are being prepared for scientific presentation and publication. Preliminary analysis of the data shows that ColorectAlert detects cancers at all stages, particularly the early stages when the cancer is curable more than 90 per cent of the time.

'With 2,200 samples examined, including both high-risk and screening subjects, we have the confidence in ColorectAlert to begin evaluating options for regulatory submissions in jurisdictions like Canada and Europe, and to begin moving it into a major multi-site screening trial building toward FDA clearance,'said Dr. Brent Norton, IMI President and CEO. 'We are exploring options for a trial of this scope, including several government-sponsored studies scheduled in 2003.'

A health economic study published earlier this year (Canadian Journal of Clinical Pharmacology, Spring 2002) demonstrated that using ColorectAlert as a first-line screening test for colorectal cancer would result in significant savings over FOBT, while detecting 43 per cent more cancers.

LungAlert

LungAlert is a non-invasive test that detects a cancer-associated marker in a sputum sample. In a pilot study presented at last year's American Thoracic Society meeting, LungAlert showed high sensitivity for lung cancer, even in the early stages when it may still be treatable. There are currently no effective screening tests available for lung cancer, despite the fact that lung cancer is by far the deadliest cancer worldwide. Lung cancer is the leading cause of cancer death for both men and women and will cause approximately 172,000 deaths in the U.S. and Canada this year.

IMI has completed an interim analysis from its current LungAlert study focused on detecting lung cancer in smokers. Results of the interim analysis are supportive of earlier findings with LungAlert, and are being prepared for submission to an upcoming scientific meeting.

'We are pressing forward with the current LungAlert study, which we expect to complete in 2003. Based on the encouraging results to date we will be evaluating our regulatory strategy and seeking new opportunities to add new trials and trial sites, potentially through commercial and government research collaborations,'said Dr. Norton.

Breast cancer

A pilot study using IMI's new test to detect breast cancer was recently completed at a major U.S. cancer center. The study used IMI's proprietary technology - the same technology upon which ColorectAlert and LungAlert are based - to detect a cancer-associated marker in samples of breast-nipple aspirate. Nipple aspirates are small amounts of fluid obtained from the breast duct, where 95 per cent of breast cancers originate. Results from the study are being prepared for presentation at an upcoming international scientific meeting.

'This new test for breast cancer promises to become a major addition to our strong portfolio of cancer-detection tests that already includes tests for colorectal and lung cancer,'said Dr. Brent Norton. 'The breast cancer test is essentially a new application of technology we're already using in the other cancers and is consistent with our strategy of identifying and capitalizing on new opportunities for our core technologies.'

'Based on the preliminary analysis of the pilot study we are formally expanding our initiative in breast cancer. We are in discussions about the design of a larger follow-up study that will expand the scientific and clinical foundation for this new approach to breast cancer screening, beginning in 2003,'said Dr. Norton.

Recent publications

Earlier this year two new papers on IMI's cancer-detection method were published, further building the scientific foundation for IMI's innovative cancer screening approach. The first paper, titled 'A Novel Method for the Quantification of the Galactose Oxidase-Schiff's Reaction and Its Use in Cancer Detection,'is authored by Dr. Michael Evelegh, IMI Executive Vice President, Clinical and Regulatory Affairs and appears in the Journal of Clinical Ligand Assay (Spring 2002). The second publication, authored by Dr. Peter Horsewood, is published as a chapter in Tumor Markers: Physiology, Pathobiology, Technology and Clinical Applications, AACC Press (Summer 2002).

About IMI

IMI is a world leader in predictive medicine. IMI is dedicated to developing rapid, non-invasive tests for the early detection and monitoring of life-threatening diseases, particularly cardiovascular disease and cancer. IMI's lead product is a non-invasive skin test for risk assessment of coronary artery disease. IMI's cancer products in development include ColorectAlert(TM), a screening test for colorectal cancer, LungAlert(TM), a screening test for lung cancer, and a new test to detect breast cancer. For further information, please visit the company's web site at www.imimedical.com.

This release contains forward-looking statements that reflect the company's current expectation regarding future events. The forward-looking statements involve risk and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company's quarterly filings.

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