OncoGenex Pharmaceuticals Completes Amendment to Phase 3 Special Protocol Assessment for Confirming Survival Benefit in Patients Receiving OGX-011 with First-Line Docetaxel for Metastatic Prostate Cancer



    BOTHELL, WA, and VANCOUVER, June 24 /CNW/ - OncoGenex Pharmaceuticals,
Inc. (NASDAQ:   OGXI) announced today that the company has reached an agreement
with the U.S. Food and Drug Administration (FDA) via the special protocol
assessment process (SPA) on an amendment to the design of a Phase 3
registration trial of OGX-011, its lead product candidate targeting castrate
resistant prostate cancer (CRPC). The FDA has agreed on modifications to the
study population of a previously reviewed Phase 3 trial featuring survival as
the primary endpoint. The study population has been modified to evaluate
patients receiving first-line chemotherapy, rather than those receiving
second-line chemotherapy. FDA agreed that the amended protocol adequately
addresses the objectives necessary to support a regulatory submission.
    "We are now ready to proceed with two Phase 3 trial designs from the FDA
via the SPA process, one in first-line and one in second-line treatment of
advanced prostate cancer," said Scott Cormack, President and CEO of OncoGenex
Pharmaceuticals. "The trial for first-line treatment evaluates overall
survival benefit for OGX-011 while the trial for second-line treatment
evaluates for a durable pain palliation benefit. Based on the robustness of
the OGX-011 survival benefit observed in the randomized Phase 2 trial for
first-line docetaxel treatment, we felt evaluating both of these patient
populations, as well as both endpoints, in our Phase 3 trials better positions
the availability of OGX-011 treatment to a larger number of men with prostate
cancer."
    The Phase 3 trial has been designed in collaboration with internationally
recognized experts in the treatment of patients with castrate resistant
prostate cancer (CRPC) including Dr. Celestia Higano at the University of
Washington and Dr. Kim Chi at the University of British Columbia. The revised
trial will be a randomized, controlled, international study in 800 men with
metastatic CRPC who are in need of first-line chemotherapy. Patients will be
randomized to receive treatment with either OGX-011 and docetaxel/prednisone
or docetaxel/prednisone alone. The primary endpoint of the study will be
overall survival. It is expected that approximately 80 sites, primarily from
United States and Canada, will participate in this study.
    The planned initiation of this Phase 3 trial evaluating survival is
supported by Phase 2 data from patients receiving OGX-011 plus docetaxel as
first-line chemotherapy presented at the 2009 Annual Meeting of the American
Society of Clinical Oncology (ASCO) and reported on May 30th of this year.
Analyses indicated the median overall survival in patients with advanced
metastatic prostate cancer who were treated with OGX-011 plus docetaxel in a
randomized Phase 2 trial was 23.8 months compared to 16.9 months for patients
treated with docetaxel alone -- a 6.9 month observed survival advantage for
the OGX-011 arm. Furthermore, the unadjusted hazard ratio (HR), a measure used
to compare the death rates between treatment groups, was 0.61, representing a
39% lower rate of death for patients treated with OGX-011.

    About OGX-011

    OGX-011 is designed to inhibit the production of clusterin, a protein
that is associated with cancer treatment resistance, and has completed Phase 2
clinical trials in prostate, lung and breast cancer.
    Based on clinical results to date, OncoGenex intends to conduct two Phase
3 registration trials with OGX-011 in metastatic castrate resistant prostate
cancer, subject to the receipt of additional funding. The U.S. Food & Drug
Administration (FDA) has now agreed on the design of both Phase 3 registration
trials, via the Special Protocol Assessment (SPA) process, of OGX-011 in
combination with chemotherapy. One trial design investigates overall survival
as the primary endpoint in patients treated with first-line docetaxel
chemotherapy; the other trial design investigates pain palliation as the
primary endpoint in patients treated with second-line docetaxel chemotherapy.
    OGX-011 has received Fast Track designation from the FDA for the
treatment of progressive metastatic prostate cancer in combination with
docetaxel.

    About the Special Protocol Assessment and Agreement Process

    Under a Special Protocol Assessment (SPA), a company and the FDA can
reach an agreement on the design and size of a clinical trial to support a
regulatory submission. This agreement can be in writing and cannot be changed
after the clinical trial begins except: (i) with written agreement of the
company and the FDA; or (ii) if the director of the FDA reviewing division
determines that "a substantial scientific issue essential to determining the
safety or effectiveness of the drug" was identified after testing began.

    About OncoGenex

    OncoGenex is a biopharmaceutical company committed to the development and
commercialization of new therapies that address unmet needs in the treatment
of cancer. OncoGenex has a deep oncology pipeline, with each product candidate
having a distinct mechanism of action and representing a unique opportunity
for cancer drug development. OGX-011, the lead candidate that has completed
five Phase 2 clinical trials in prostate, lung and breast cancers, is designed
to inhibit the production of a specific protein associated with treatment
resistance; OGX-427 is in Phase 1 clinical development; SN2310 has completed
the Phase 1 clinical trial; and CSP-9222 and OGX-225 are currently in
pre-clinical development.
    OGX-011, OGX-427 and OGX-225 utilize second-generation antisense
technology, licensed from Isis Pharmaceuticals (NASDAQ:   ISIS), to effectively
target and inhibit production of specific proteins in tumor cells. OncoGenex
and Isis partnered in the successful discovery of OGX-011, OGX-427 and OGX-225
and with respect to OGX-011, in its initial development. In 2008, OncoGenex
and Isis amended their OGX-011 agreement to provide OncoGenex with sole rights
to OGX-011 and sole responsibility for development and related costs and
partnering decisions, subject to financial obligations to Isis. OncoGenex is
also solely responsible for development and related costs and partnering
decisions regarding OGX-427 and OGX-225. Key intellectual property related to
OGX-011, OGX-427 and OGX-225 were discovered by the University of British
Columbia and the Vancouver Prostate Centre, and were exclusively licensed to
OncoGenex.
    More information about OncoGenex is available at www.oncogenex.com.

    This press release contains forward-looking statements within the meaning
of the "safe harbor" provisions of the Private Securities Litigation Reform
Act of 1995, including statements concerning the potential survival benefit of
OGX-011, anticipated clinical development activities, timing of these
activities, the ability of future trials to demonstrate clinical benefit and
the potential for regulatory approvals. All statements other than statements
of historical fact are statements that could be deemed forward-looking
statements. These statements are based on management's current expectations
and beliefs and are subject to a number of risks, uncertainties and
assumptions that could cause actual results to differ materially from those
described in the forward-looking statements.
    The potential risks and uncertainties associated with forward-looking
statements include, among others, the possibility that any benefit in patient
survival will not be maintained or will become less substantial as patient
survival follow up continues, risks that clinical trials will not be
successful or confirm earlier clinical trial results, including the risk that
the survival benefit will not be confirmed by a Phase 3 clinical trial, risks
associated with obtaining funding from third parties or completing a financing
necessary to support the costs and expenses of a Phase 3 clinical trial, the
timing and costs of clinical trials and regulatory approvals will be different
than management currently anticipates, risks relating to the development,
safety and efficacy of therapeutic drugs and potential applications for these
products and the risk factors set forth in the Company's filings with the
Securities and Exchange Commission, including the Company's Annual Report on
Form 10-K for fiscal year 2008. The Company undertakes no obligation to update
the forward-looking statements contained herein or to reflect events or
circumstances occurring after the date hereof.





For further information:

For further information: OncoGenex Contact: Scott Cormack, President &
CEO, (604) 736-3678, scormack@oncogenex.com; Media and Investor Contact: Jason
Spark, Porter Novelli Life Sciences, (619) 849-6005,
jspark@pnlifesciences.com


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