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OncoGenex Pharmaceuticals Announces OGX-427 Treatment Demonstrates Safety, Evidence of Declines in Circulating Tumor Cells and Reductions in Tumor Markers in a Phase 1 Cancer Trial
Date:5/30/2009

not met at the highest dose evaluated as monotherapy (1000 mg). - No evidence of altered cardiac activity was observed. - Majority of adverse events were mild and mainly occurred during the loading doses. Adverse events consisted of chills, itching and fatigue in over a third of patients. - There was a trend for increasing incidence of some mild adverse events with escalating OGX-427 doses. For example, 33% of patients at the 200-mg dose compared to 67% of patients at the 1000-mg dose had mild adverse events during the loading doses. - The half-life of OGX-427 in the blood remained constant, although there appeared to be an increase in maximum blood levels and a corresponding decease in blood clearance of OGX-427 as doses were escalated.

The combination of 800 mg OGX-427 with docetaxel was also well tolerated and escalation to 1000 mg OGX-427 with docetaxel will be evaluated next.

Circulating Tumor Cell and Tumor Marker Results

Circulating tumor cells (CTCs), an emerging metric to assess treatment effect, was evaluated at baseline before treatment and during treatment. Both total and Hsp27-positive CTCs were evaluated. Declines of 50% or greater in both total and Hsp27-positive CTCs were observed in over half of the patients in each cohort and in each cancer category. Declines in Hsp27 CTCs to 5 or less cells occurred in 27% of patients who had greater than 5 CTCs at baseline.

Reduction in tumor markers defined as declines of PSA levels in prostate cancer or CA-125 levels in ovarian cancer were also observed. A reduction in PSA level was observed in 7 of 20 patients (35%) with prostate cancer and a reduction in CA-125 levels was observed in 3 of 5 patients (60%) with ovarian cancer.

"CTCs are emerging as an exciting surrogate of anti-cancer activity. The frequent decreases in total
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SOURCE OncoGenex Pharmaceuticals, Inc.
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