Med BioGene Inc.

Med BioGene Inc.

October 15, 2009 08:30 ET

Med BioGene Announces Positive Results From Validation Study of LungExpress DX™

Studies confirm that LungExpress Dx™ is an independent prognostic marker in early-stage non-small-cell lung cancer that may provide additional clinical value beyond standard measures of risk.

VANCOUVER, BRITISH COLUMBIA--(Marketwire - Oct. 15, 2009) - Med BioGene Inc. (TSX VENTURE:MBI) today announced positive results from the current validation study of LungExpress Dx™ undertaken by MBI and its collaborators at the University Health Network (Princess Margaret Hospital) in Toronto.

The study met its primary endpoint in confirming that the 15-gene expression-based assay underlying LungExpress Dx™ is an independent prognostic marker in early-stage non-small-cell lung cancer (NSCLC) for identifying, more selectively than routine staging, patients with significantly different prognoses and may provide additional clinical value beyond standard measures of risk. MBI and UHN expect to submit for publication the detailed results of the study.

"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."

The study was performed in an independent set of tumour samples from 183 untreated stage I and II NSCLC patients (predominantly adenocarcinoma and squamous cell carcinoma) collected over a five-year period. To date, the prognostic utility of LungExpress Dx™ has been validated in approximately 675 patient samples.

Based upon these positive results, MBI is continuing with its commercialization plans to make LungExpress Dx™ available to physicians and patients initially in the United States in early 2010.

"We are very pleased with the positive findings from this important validation study," said Erinn B. Broshko, Chief Executive Officer of MBI. "The results confirm the biological robustness of LungExpress Dx™ and move us closer to introducing commercially the first multi-gene prognostic test for early-stage non-small-cell lung cancer."

"This test may improve patient care by providing a clearer understanding of each patient's risk of cancer recurrence after surgery, potentially resulting in better-informed, more appropriate treatment decisions. We are moving closer to the ultimate goal of personalized medicine," said Dr. Frances A. Shepherd of the University Health Network.

About LungExpress Dx™

LungExpress Dx™ is a proprietary 15-gene expression-based assay that classifies patients into high and low risk prognostic groups based upon the molecular profile of a particular patient's tumour and is expected to be used in conjunction with existing clinical parameters to provide additional independent clinical value beyond standard measures of risk.

The original study presented at the 2008 Annual Meeting of the American Society of Clinical Oncology involving tumour samples collected prospectively from patients participating in an adjuvant chemotherapy (cisplatin / vinorelbine) clinical trial showed that those patients classified by LungExpress Dx™ as high risk benefitted, and those classified as low risk did not benefit, from adjuvant chemotherapy following resection of their tumour.

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 tumor, lymph node involvement and metastatic status) remains the strongest predictor of survival but fails to account for this difference in patient outcomes. LungExpress Dx™ is expected to help address this critical issue.

University Health Network and Princess Margaret Hospital

LungExpress Dx™ is being developed in collaboration with a team of internationally acclaimed researchers and physicians at the Princess Margaret Hospital in Toronto. 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 Past-Chair of the National Cancer Institute of Canada Clinical Trials Group Lung Cancer Site. Drs. Tsao and Shepherd are Professors at the University of Toronto and have in total authored more than 500 articles in peer reviewed journals.

Princess Margaret Hospital, a research hospital of the University of Toronto, has achieved an international reputation as a global leader in the fight against cancer and is considered one of the top comprehensive cancer treatment and research centres in the world. Located in Toronto, Princess Margaret Hospital, together with its research institute, the Ontario Cancer Institute, is a member of the University Health Network, which also includes the Toronto General Hospital and the Toronto Western Hospital. Princess Margaret Hospital is the only facility in Canada devoted exclusively to cancer research, treatment and education.

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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