OncoGenex Technologies Announces Phase II Data of OGX-011 in Metastatic Breast Cancer at American Association for Cancer Research 2007 Annual Meeting



    VANCOUVER, April 17 /CNW/ - OncoGenex Technologies Inc. announced today
data from a Phase II clinical trial of OGX-011 in combination with docetaxel
in patients with metastatic breast cancer (MBC). Data was presented by the
National Cancer Institute of Canada - Clinical Trials Group at the American
Association for Cancer Research 2007 Annual Meeting in Los Angeles, Calif.
    
    Investigators concluded:
        -  Of the 15 patients treated, five patients (33.3 percent) showed a
           partial response and nine patients (60 percent) showed disease
           stabilization
        -  Of the nine patients reported with stable disease, tumor reduction
           ranged from approximately one to 23 percent and disease
           stabilization was sustained for a median of 9.3 months
        -  Only one patient advanced to progressive disease
        -  While patient monitoring is ongoing, the median progression free
           survival for all patients was eight months and the median time for
           survival has not yet been reached
        -  Clinical activity was seen for the combination of OGX-011 and
           docetaxel in this generally pre-treated group of patients with
           MBC, but did not meet the pre-determined criteria of six or more
           patients achieving tumour size reductions exceeding 30 percent
           required to expand the trial into a second stage of accrual
        -  Serum clusterin levels fell on treatment in most patients, and
           there was no statistical correlation between changes from baseline
           in clusterin levels and objective tumor response
    

    "Taxanes represent an active class of chemotherapeutic agents currently
used in the treatment of breast cancer, however the majority of patients will
eventually develop resistance to the therapies," said Dr. Stephen Chia,
Principal Investigator for this study and Medical Oncologist at the BC Cancer
Agency. "The finding that all but one patient showed some degree of clinical
benefit and the median duration of disease stabilization exceeded nine months
is of interest in this small study."
    "We are encouraged by the conclusion made by the investigators that the
combination of OGX-011 and docetaxel has activity in this patient population
and by the very low incidence of progressive disease," said Scott Cormack,
president and CEO of OncoGenex. "As provided in our previous guidance, these
data together with the data from our other Phase II programs in prostate
cancer and non-small cell lung cancer, scheduled to be released later this
year, will be considered in our planning for subsequent studies, including
pivotal trials."
    The primary objective of this study was to assess the objective response
rates (reduction in tumor size) when OGX-011 is combined with docetaxel in
patients with metastatic or locally recurrent breast cancer. Secondary
endpoints included estimation of time to disease progression, overall survival
and the effect of OGX-011 on serum clusterin.
    Fifteen patients were enrolled and all were evaluable for toxicity and
response. A median of six treatment cycles were delivered. Grade 3 adverse
events commonly associated with chemotherapy alone included: fatigue
(33 percent), vomiting (13 percent), edema (13 percent), arthralgias (13
percent) and dyspnea (13 percent). Five patients experienced febrile
neutropenia. Investigators concluded that OGX-011 is well tolerated in
combination with docetaxel.
    Women with measurable metastatic breast cancer and no more than one
previous chemotherapy regimen for MBC were eligible for this study. OGX-011
was delivered three times at 640 mg intravenously as a loading phase prior to
initiating chemotherapy. The loading phase was followed by a weekly dose of
640 mg of OGX-011 in combination with 75 mg/m2 of docetaxel. Response was
evaluated following every second cycle.
    OGX-011 is designed to specifically inhibit the production of the
cell-survival protein, clusterin. Clusterin production is associated with
treatment resistance in many cancers and in response to various cancer
treatments, including hormone ablation therapy, chemotherapy and radiation
therapy. Preclinical studies have shown that inhibition of clusterin can
disable the tumor cell's adaptive defences, render the tumor cells susceptible
to attack with a variety of cancer therapies, including chemotherapy, and
facilitate tumor cell death. OncoGenex is developing OGX-011 in collaboration
with Isis Pharmaceuticals Inc.
    The study was sponsored by the National Cancer Institute of Canada -
Clinical Trials Group with support provided by OncoGenex Technologies Inc.

    About OncoGenex
    OncoGenex is committed to the development and commercialization of new
cancer therapies that address treatment resistance in cancer patients.
OncoGenex currently has three product candidates in development: OGX-011, 
OGX-427 and OGX-225. These product candidates are designed to selectively
inhibit the production of proteins that are associated with treatment
resistance and that are over-produced in response to a variety of cancer
treatments. OncoGenex' aim in targeting these particular proteins is to
disable the tumor cells' adaptive defenses, render the tumor cells susceptible
to attack with a variety of cancer therapies including chemotherapy, and
facilitate tumor cell death. More information on OncoGenex and the company's
pipeline is available at www.oncogenex.ca.





For further information:

For further information: OncoGenex Contact: Scott Cormack, President &
CEO, (604) 630-5400; Media Contact: Jason Spark, Porter Novelli Life Sciences,
(619) 849-6005

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ONCOGENEX TECHNOLOGIES INC.

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