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OncoGenex Provides Update on Two-Year Survival Data from Ongoing Phase 1/2 Clinical Trial of OGX-011 in Non-Small Cell Lung Cancer
Date:2/4/2009

ith a standard first-line NSCLC chemotherapy regimen that included a platinum-based regimen plus gemcitabine. 51% of patients had adenocarcinoma, 16% had squamous cell carcinoma and 33% of patients had undifferentiated or unspecified non-small cell lung cancer. The primary objectives of the study were designed to estimate objective response rates of OGX-011 in combination with a gemcitabine/platinum-based regimen, establish the recommended dose of OGX-011, and determine the safety and tolerability. Secondary objectives were aimed to estimate the progression-free survival, overall survival, the pharmacokinetic profile of OGX-011, and the effect of OGX-011 on serum clusterin levels.

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    Median Follow-up                                  33 months
    Number of Patients Alive (follow up ongoing)      16/81 (20%)
    Median Overall Survival                           14.1 months (0.13-45.9)
    Number of Pts Surviving
              Greater than or equal to 12 months      54% (43%-64%: 95% CI)
              Greater than or equal to 18 months(1)   39% (28%-49%: 95% CI)
              Greater than or equal to 2 years(1)     30% (21%-40%: 95% CI)
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    (1) Kaplan-Meier Estimates

69% of patients experienced disease control (complete response =1%, partial response =30%, stable disease =38%), 26% experienced disease progression, and response was not assessable in 5%. Median progression-free survival was 4.6 months (0.06 - 17.7 months). Investigators concluded that the treatment with OGX-011 was generally well tolerated, and toxicities were consistent with the adverse event profile for gemcitabine in combination with a platinum-based regimen in this population.

Serum clusterin analysis for this NSCLC study showed that OGX-011 treatment significantly decreased the mean ave
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SOURCE OncoGenex Pharmaceuticals, Inc.
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