ONCOGENEX BEGINS PHASE II TRIALS OF OGX-011
OncoGenex Technologies announced the initiation of a Phase II clinical trial
of OGX-011 in newly diagnosed, previously untreated patients with clinically
localized, high-risk prostate carcinoma. OGX-011 is a second-generation antisense
drug designed to specifically inhibit the production of clusterin, a cell-survival
protein that is up-regulated in response to standard anticancer treatments.
This study will enroll up to 45 newly diagnosed, previously untreated patients.
Patients will receive two-hour intravenous infusions of OGX-011 weekly, plus
concomitant hormone ablation therapy for 12 weeks prior to radical prostatectomy.
Increased clusterin expression protects prostate cancer cells from the cytotoxic
effects of hormone ablation and chemotherapy and elevated levels of clusterin
are associated with hormone resistance and metastasis.
Preliminary results from three Phase I trials show that OGX-011 is well-tolerated,
achieves excellent drug concentrations in prostate tissue, and produces a 91
percent dose-dependent down-regulation of clusterin in prostate cancer cells
removed from prostate cancer patients. Additional Phase II clinical trials in
breast, prostate and lung cancer will begin later this year.