Med BioGene Inc.
TSX VENTURE : MBI

Med BioGene Inc.

March 18, 2009 13:10 ET

Med BioGene Expands Collaboration With University Health Network for Novel Gene-Markers Predictive of Chemotherapy Response in Lung Cancer

Initial studies show LungExpress Dx™ has the potential to select patients with an increased benefit from chemotherapy and to decrease treatment costs significantly.

VANCOUVER, BRITISH COLUMBIA--(Marketwire - March 18, 2009) - Med BioGene Inc. (TSX VENTURE:MBI) today announced that it has expanded its previous exclusive license and collaboration with the University Health Network in Toronto to develop and commercialize LungExpress Dx™ to include additional novel gene expression-based markers for early-stage non-small-cell lung cancer (NSCLC).

LungExpress Dx™ is a proprietary gene expression-based assay for early-stage NSCLC that will be used to predict a patient's prognosis for survival and the magnitude of benefit for adjuvant chemotherapy.

"Not all patients benefit from chemotherapy and not all patients require chemotherapy after surgery," said Dr. Ming-Sound Tsao of the University Health Network. "Knowing that a patient has a genetic signature for a more aggressive cancer and that their chance of cure may be improved with chemotherapy gives patients and their doctors a clearer picture of the need for post-operative treatment."

LungExpress Dx™ is intended to classify patients into high and low risk groups based upon the molecular profile of an individual patient's tumour. The test is expected to be used to improve the selection of patients beyond current clinical parameters, such as stage and histology, for adjuvant chemotherapy. LungExpress Dx™ will be the only multi-gene test shown to be predictive of benefit from adjuvant chemotherapy. Initial studies have demonstrated that patients identified using the genomic signatures incorporated into LungExpress Dx™ as being at high risk benefited significantly from adjuvant chemotherapy whereas patients identified as low risk did not benefit.

By better selecting patients for adjuvant chemotherapy, LungExpress Dx™ has the potential to increase the five-year survival rate by up to 33% while decreasing health care costs significantly. The main reason for the expected cost savings is a decrease in treatment failure and terminal care costs associated with cancer recurrence; these costs in the United States can range from between $150,000 to $500,000 per patient.

Erinn Broshko, Chief Executive Officer of MBI noted "We are pleased to be extending our relationship with the University Health Network, and, in particular, its world-class team of lung cancer clinical researchers. Importantly, we now have clinical data demonstrating that the genomic signature incorporated into LungExpress Dx™ has the potential to increase the cure rate of early stage lung cancer and save the health care system millions of dollars in costs."

Data regarding the newly licensed genomic signature was presented at the 2008 Annual Meeting of the American Society of Clinical Oncology where it was awarded the distinction of being included in the Official Press Program; fewer than 1% of meeting abstracts receive this distinction (www.asco.org/ASCO/Abstracts+%26+Virtual+Meeting/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=32591).

Treatment of Early-Stage Non-Small-Cell Lung Cancer

Early-stage NSCLC patients are treated primarily by surgical removal of their tumours. Recent clinical trials have established that adjuvant chemotherapy, administered after tumour removal, significantly improves the survival of stage II patients, but does not significantly improve the survival of stage I patients. As a result, the American Society of Clinical Oncology and National Comprehensive Cancer Network recommend adjuvant chemotherapy for stage II patients but not for stage I patients.

However, 30% to 55% of stage I and II patients still die as a result of the disease, implying that patients diagnosed with the same stage of disease can have markedly different treatment responses and overall outcomes. Currently, tumor stage (determined by the size and location of the tumour and lymph node involvement) remains the strongest predictor of survival but fails to account for this difference in patient outcomes. LungExpress Dx™ is expected to address this critical issue.

University Health Network Collaborators

LungExpress Dx™ is being developed in collaboration with a team of internationally acclaimed researchers and physicians at the Princess Margaret Hospital in Toronto, the cancer research and treatment hospital within the University Health Network. The team is led by Dr. Ming-Sound Tsao, holder of the M. Qasim Choksi Chair in Lung Cancer Translational Research, and Dr. Frances A. Shepherd, holder of the Scott Taylor Chair in Lung Cancer Research and the Chair of the National Cancer Institute of Canada Clinical Trials Group Lung Cancer Site. Drs. Tsao and Shepherd have in total authored more than 400 articles in peer reviewed journals.

About Med BioGene

MBI is a life science company focused on the development and commercialization of genomic-based personalized clinical laboratory diagnostic tests for cancer.

MBI's lead product, LungExpress Dx™, is expected to be the first commercially available test using gene expression technology to assist in predicting the individual prognosis and magnitude of chemotherapy benefit for patients inflicted with early-stage non-small-cell lung cancer. LungExpress Dx™ will provide to patients and their physicians valuable information in order to more effectively guide treatment and improve the selection of patients for adjuvant chemotherapy.

MBI is committed to advancing personalized medicine by commercializing tests that provide actionable information to both save lives and reduce health care costs.

Certain statements in this press release contain forward-looking information under applicable Canadian securities legislation. Words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "will," "would" and similar expressions are intended to identify forward-looking information, although not all forward-looking information contains these identifying words. Forward looking information includes, but is not limited to, that with respect to future profits, future product revenues, future operations and plans, the use of proceeds from financings, the timing of clinical trials and the completion date for clinical trials and the prospects for negotiating partnerships or collaborations and their timing. This forward-looking information is only a prediction based upon MBI's current expectations, and actual events or results may differ materially. MBI may not actually achieve the plans, intentions or expectations disclosed in its forward-looking information. Forward-looking information is subject to known and unknown risks and uncertainties and is based on uncertain assumptions that could cause MBI's actual results and the timing of events to differ materially from those anticipated in such forward-looking information. You are cautioned not to place undue reliance on this forward-looking information, which speaks only as of the date of this press release. MBI's forward-looking information does not reflect the potential impact of any future partnerships, collaborations, acquisitions, mergers, dispositions, joint ventures or investments that MBI may make. All forward-looking information is qualified in its entirety by this cautionary statement and MBI undertakes no obligation to revise or update any forward-looking information as a result of new information, future events or otherwise after the date of this press release, other than as required by applicable law.

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