OncoGenex reports lead drug candidate OGX-011 achieved primary endpoint in Phase 2 Trial with second-line chemotherapy for prost... (p not manifested disease progression ...)

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OncoGenex reports lead drug candidate OGX-011 achieved primary endpoint in Phase 2 Trial with second-line chemotherapy for prostate cancer

Date:2/15/2008

p> not manifested disease progression and approximately 60 percent of

patients remain alive in both arms. Median survival has not been

reached in either arm. These data compare favorably with published

results documenting median survivals of approximately 10 months.

- Reduction in pain or analgesic use was achieved in 50 percent or more

of patients entering the study with pain: Reductions in pain or

analgesic use were seen in 50 percent of evaluable patients treated

with mitoxantrone and in 67 percent of evaluable patients retreated

with docetaxel. These data compare favorably to the 22-35 percent of

patients receiving first-line chemotherapy who reported reduction in

pain in the TAX 327 study published in the New England Journal of

Medicine on October 7, 2004.

This Phase 2 study was designed as an open-label, randomized, multicenter study evaluating weekly administration of OGX-011 in combination with second-line chemotherapy in patients with metastatic hormone refractory prostate cancer who were previously treated with a minimum of 2 cycles of docetaxel-based first-line chemotherapy. Patients in this study represented a poor prognostic population due to rapid disease progression after completing first-line docetaxel therapy with a median of 0.7 months in the mitoxantrone treated group or 2.1 months in the docetaxel retreated group. Because OGX-011 has been shown to enhance chemotherapy and reverse chemotherapy resistance in preclinical in vitro and in vivo models, the aim of this study was to assess the effect of OGX-011 in combination with either mitoxantrone or docetaxel retreatment as second-line chemotherapy. Phase 3 studies are planned utilizing chemotherapy plus OGX-011 as second-line therapy in patients progressing after a first-line docetaxel regimen.

"These data show that the combination of OGX-011 with docetaxel or mitoxantrone may
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OncoGenex reports lead drug candidate OGX-011 achieved primary endpoint in Phase 2 Trial with second-line chemotherapy for prost...(p not manifested disease progression ...)