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
|SOURCE OncoGenex Technologies Inc.|
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