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Response Genetics Announces Publication of a Phase III Clinical,Trial Demonstrating That Low Levels of ERCC-1 Help to Predict,Likelihood of Response to Cisplatin-Based Therapy in Lung Cancer

- First prospective biomarker trial in non-small cell lung cancer -

LOS ANGELES, July 09, 2007 /PRNewswire-FirstCall/ -- Response Genetics, Inc. today announced that positive Phase III clinical data published in the July 1 issue of the Journal of Clinical Oncology suggests that low expression of the biomarker Excision-Repair Cross-Complementing 1 (ERCC-1) in patient biopsies with advanced non-small cell lung cancer (NSCLC) predicts for sensitivity to cisplatin-based chemotherapy. ERCC-1 is an enzyme involved in repair of DNA strand breaks such as those caused by cisplatin. The analysis of ERCC-1 levels in this study was conducted by Response Genetics using its RGI-1 technology. Data from previous studies published by the Company in Clinical Cancer Research 2002 and Annals of Oncology 2006 showing that ERCC-1 was associated with tumor sensitivity to cisplatin formed the basis for the present study. This is the first prospective study using a biomarker to predict chemotherapy response in lung cancer. These findings support the use of measurement of ERCC-1 for individualizing therapies for lung cancer patients.

The Phase III multicenter, randomized study was designed to determine the overall response rate (complete plus partial responses) of patients with stage IIIb or IV NSCLC to cisplatin-based therapy by determining levels of the biomarker ERCC-1 mRNA in their paraffin-embedded tissue biopsy before administering treatment. Patients were prospectively assigned treatment to a cisplatin or non-cisplatin-based chemotherapy depending on whether the ERCC-1 gene expression in their tumor sample was above or below a specific threshold. Patients were assigned to one of two arms in this trial. The control arm consisted of all patients receiving cisplatin-based therapy. Patients in the "genotypic" arm were separated by levels of ERCC-1. Cisplatin-based therapy (docetaxel/cisplatin) was assigned to patients with low
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