OncoGenex reports lead drug candidate OGX-011 achieved primary endpoint in Phase 2 Trial for prostate cancer
OncoGenex Technologies Inc. announced that the Company's lead cancer drug candidate, OGX-011, also referred to as custirsen, was well-tolerated in combination with either docetaxel or mitoxantrone administered as second-line chemotherapy in patients with hormone refractory prostate cancer. Additionally, patients treated with second-line chemotherapy plus OGX-011 showed ongoing survival durations better than results published with chemotherapy alone. Phase 2 data were presented at the 2008 Genitourinary Cancers Symposium. OncoGenex and Isis Pharmaceuticals, Inc. are collaborating on development of OGX-011.
According to data presented by Dr. Fred Saad, Professor of Surgery/Urology at the University of Montreal, the primary objectives of safety and tolerability were achieved in the 42 patients evaluated in the study. In addition, encouraging outcomes were observed with OGX-011 administered in combination with second-line chemotherapy.
More chemotherapy than expected was safely administered to and tolerated by patients when OGX-011 was combined with second-line chemotherapy: Patients received a median of 6 cycles of mitoxantrone or 7.5 cycles of docetaxel as second-line chemotherapy. These data compare favorably with published reports documenting a median of 3-4 cycles with second-line chemotherapy alone.
Survival was better than expected based on previously published reports: With a median follow-up of 13.3 months following second-line chemotherapy, approximately 30 percent of patients in both arms have 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 2004.
OGX-011 is designed to block production of clusterin, a cell survival protein that is over-produced in several cancer indications and in response to many cancer treatments, including hormone ablation therapy, chemotherapy and radiation therapy. Increased clusterin production is observed in many human cancers, including prostate, non-small cell lung, breast, ovarian, bladder, renal, pancreatic, anaplastic large cell lymphoma and colon cancers and melanoma. Increased clusterin production is linked to faster rates of cancer progression, treatment resistance and shorter survival duration.
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