OncoGenex Initiates Phase II Clinical Trial of OGX-011 in Hormone Refractory Prostate Cancer

OncoGenex Technologies Inc. has started a phase II clinical trial of OGX-011, a second-generation antisense drug designed to inhibit the production of clusterin, a cell-survival protein associated with resistance to standard anti-cancer treatments. This trial is the third of four phase II studies OncoGenex has planned for OGX-011 in 2005. The company is developing OGX-011 in collaboration with Isis Pharmaceuticals Inc. (ISIS) and is coordinating the trial with the U.S. National Cancer Institute of Canada Clinical Trials Group. The study aims to accrue a total of 80 patients with hormone refractory prostate cancer (HRPC) and will evaluate the effect of OGX-011 and docetaxel on PSA, duration of response, serum clusterin levels, and overall survival.

Key Takeaways:

OncoGenex Technologies Inc. has initiated a phase II clinical trial of OGX-011 in hormone refractory prostate cancer patients, with a total of 80 patients planned for accrual.
OGX-011 is a second-generation antisense drug designed to inhibit the production of clusterin, a cell-survival protein associated with resistance to standard anti-cancer treatments.
The study will evaluate the effect of OGX-011 and docetaxel on PSA, duration of response, serum clusterin levels, and overall survival in patients with hormone refractory prostate cancer.
OncoGenex is developing OGX-011 in collaboration with Isis Pharmaceuticals Inc. (ISIS) and is coordinating the trial with the U.S. National Cancer Institute of Canada Clinical Trials Group.
Preliminary results from three phase I clinical trials show that OGX-011 is well tolerated, achieves excellent drug concentrations in prostate tissue, can be combined safely with chemotherapy, and produces a 91% dose-dependent down-regulation of clusterin in prostate cancer cells.
Two phase II clinical trials in prostate and lung cancer were initiated earlier this year, and a fourth study in breast cancer will be initiated by year end.

Statistics:

Total of 80 patients planned for accrual in the phase II clinical trial of OGX-011.
OGX-011 has shown a 91% dose-dependent down-regulation of clusterin in prostate cancer cells in preliminary phase I clinical trials.
OncoGenex has planned four phase II studies for OGX-011 in 2005.
Three phase I clinical trials have evaluated OGX-011, showing excellent drug concentrations in prostate tissue, safe combination with chemotherapy, and dose-dependent down-regulation of clusterin.

Sources:

Health & Medicine Week editors from staff and other reports.