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



    Data presented at the 2008 Genitourinary Cancers Symposium

    VANCOUVER, Feb. 15 /CNW/ - OncoGenex Technologies Inc. announced today
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 today
at the 2008 Genitourinary Cancers Symposium. OncoGenex and Isis
Pharmaceuticals, Inc. (Nasdaq:   ISIS) 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 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 improve treatment outcomes in second-line prostate cancer,"
said Dr. Fred Saad, who is also the primary investigator in the study. "The
data also suggests that retreatment with docetaxel when combined with OGX-011
may reverse chemotherapy resistance in second-line docetaxel retreatment. We
look forward to confirming these data in planned Phase 3 studies."

    About OGX-011

    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. Clusterin
levels may be further increased in response to standard cancer therapies,
including hormone ablation therapy, chemotherapy and radiation therapy.
Clusterin expression is linked to disease progression, treatment resistance,
poor prognosis and survival in scientific publications. For example, increased
expression of clusterin in prostate cancer is closely correlated with
increasing Gleason score, which is a strong prognostic factor for poor
survival of patients with prostate cancer.

    About OncoGenex

    OncoGenex is a private biopharmaceutical company committed to the
development and commercialization of new cancer therapies that address
treatment resistance in cancer patients. The company's three product
candidates are designed to inhibit the production of specific proteins
associated with treatment resistance and which are over-produced in response
to a variety of cancer treatments. OGX-011 is completing evaluation in five
Phase 2 clinical studies in prostate, lung, and breast cancers. OGX 427 has
begun evaluation in Phase 1 clinical studies, while the third product
candidate, OGX-225, has completed preclinical pharmacology studies. More
information is available at www.oncogenex.ca.





For further information:

For further information: OncoGenex Contact: Scott Cormack, President &
CEO, (604) 805-2274, scormack@oncogenex.ca; OncoGenex Media Contact: Jason
Spark, Porter Novelli Life Sciences, (619) 849-6005,
jspark@pnlifesciences.com

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ONCOGENEX TECHNOLOGIES INC.

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