Med BioGene Inc. (TSX VENTURE:MBI) today announced positive results from the current validation study of LungExpress DxTM 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 DxTM 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 DxTM has been validated in approximately 675 patient samples.

Based upon these positive results, MBI is continuing with its commercialization plans to make LungExpress DxTM 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 DxTM 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 DxTM

LungExpress DxTM 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 DxTM 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 DxTM is expected to help address this critical issue.

Source
University Health Network and Princess Margaret Hospital