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/R E P E A T -- Oncolytics Biotech Inc. Announces U.S. Phase 2 Combination Clinical Trial for Non-Small Cell Lung Cancer Patients with K-RAS or EGFR-Activated Tumours/
Date:9/2/2008

gene amplification in their tumours (metastatic or primary) in order to qualify for the trial.

The primary objectives of the Phase 2 trial are to determine the objective response rate of REOLYSIN(R) in combination with paclitaxel and carboplatin in patients with metastatic or recurrent NSCLC with K-RAS or EGFR-activated tumours, and to measure progression-free survival at 6 months. The secondary objectives are to determine the median survival and duration of progression-free survival in patients, and to evaluate the safety and tolerability of REOLYSIN(R) in combination with paclitaxel and carboplatin in this patient population.

REOLYSIN(R) preferentially replicates in cancer cells that have an activated RAS pathway. Approximately two thirds of all cancers have an activated RAS pathway, including most metastatic disease. A large number of mutations, including mutations in EGFR, Her2 or K-RAS along the RAS pathway lead to RAS pathway activation.

Recent clinical studies in NSCLC with EGFR-based therapies have shown that patients with mutations or overexpression of EGFR, which are commonly found in NSCLC, derive clinical benefit from these therapies. An agent such as REOLYSIN(R) that selectively replicates in cancers with an activated RAS pathway resulting from EGFR mutations or overexpression may show similar benefit. However, patients with mutant K-RAS, or up to 20% of the more than 180,000 patients diagnosed every year in the U.S. with NSCLC, do not derive benefit from EGFR-based therapies. The introduction of screening for K-RAS mutations, and the exclusion of K-RAS mutated patients will lead to higher response rates in EGFR-mutated or overexpressed patients treated with EGFR-based therapies. This excluded patient group is therefore prescreened for RAS pathway activation resulting from mutations in K-RAS, and an agent such as REOLYSIN(R) may be indicated for this patient group. This study targets patients with either EGFR-activated tumours or K
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