OncoGenex receives completed Special Protocol Assessment for primary registration study of lead drug candidate OGX-011



    VANCOUVER, July 14 /CNW/ - OncoGenex Technologies Inc. announced today
that the company has reached an agreement with the U.S. Food and Drug
Administration (FDA) on the design of a Phase 3 registration trial of OGX-011,
its lead product candidate targeting hormone refractory prostate cancer, via
the Special Protocol Assessment (SPA) process. In the letter responding to the
OncoGenex submission, the FDA stated that they agreed with the design and
planned analysis proposed by OncoGenex, and that the study design adequately
addresses the objectives necessary to support a regulatory submission.
    The Phase 3 trial has been designed in collaboration with internationally
recognized experts in the treatment of patients with hormone-refractory
prostate cancer (HRPC) including Dr. Celestia Higano at the University of
Washington and Dr. Kim Chi at the University of British Columbia. This will be
a randomized, controlled, international study in 765 men with metastatic HRPC
who responded to first-line docetaxel therapy, but subsequently progressed and
are in need of second-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 in the United States and
Canada will participate in this study.
    "Patients who have progressed after receiving docetaxel as first-line
chemotherapy have few options," said Cindy Jacobs, M.D., Ph.D., OncoGenex'
Executive Vice-President and Chief Medical Officer. "A recent survey of 130
oncologists practicing in Canada and the United States indicates that their
primary option for patients who responded to first-line docetaxel is
retreatment with docetaxel. This is not surprising since the only product
shown to increase survival in patients with HRPC is docetaxel."
    Dr. Jacobs added, "Preliminary data from Phase 2 studies of OGX-011 in
combination with docetaxel retreatment have indicated that OGX-011 may help
restore tumor sensitivity to docetaxel and may improve overall survival for
second-line therapy."
    The planned initiation of this Phase 3 trial is supported by encouraging
preliminary Phase 2 data that were presented at the 2008 annual meeting of the
American Society of Clinical Oncology (ASCO). These preliminary data are
derived from a Phase 2 study evaluating 42 patients with HRPC who had received
first-line docetaxel therapy and required second-line chemotherapy: 22
patients were treated with mitoxantrone plus OGX-011 and 20 patients with
docetaxel retreatment plus OGX-011. While follow up on surviving patients is
still ongoing, the following preliminary findings were reported:

    
    - Survival continued to be better than expected based on previously
      published reports: With a median follow-up of 17.2 months following the
      start of second-line chemotherapy, median survival has been estimated
      at 11.4 months in the mitoxantrone plus OGX-011 group and 14.7 months
      in the docetaxel retreatment plus OGX-011 group. These data compare
      favorably with published results reporting median survivals at
      approximately 10 months for HRPC patients receiving second-line
      chemotherapy without OGX-011.

    - In addition, average serum clusterin levels during treatment were
      predictive of survival, with low-average levels predicting median
      survival time of 14.7 months compared to high-average levels predicting
      median survival time of 5.5 months. These data suggest that a reduction
      in clusterin levels may improve survival.
    

    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. 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 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 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.

    Definitive Agreement to Merge

    On May 28, 2008, Sonus Pharmaceuticals, Inc. (NASDAQ:   SNUS) and OncoGenex
Technologies Inc., jointly announced the signing of a definitive agreement to
merge the two companies. The combined company will operate as OncoGenex
Pharmaceuticals, Inc. The proposed transaction received unanimous approval
from the Boards of Directors of Sonus and OncoGenex, and is expected to be
completed in the third quarter of 2008, subject to the satisfaction of certain
conditions, including the approval of Sonus' and OncoGenex' shareholders and,
in the case of OncoGenex, court approval under the arrangement provisions of
the Canada Business Corporations Act. OncoGenex management believes that the
completion of this SPA for OGX-011 will result in the release of 25% of the
escrowed shares that will be issued to OncoGenex shareholders at the
completion of the merger pursuant to the Escrow Agreement described in the
Proxy Statement and related materials filed by Sonus with the SEC. A final
determination of the satisfaction of the release conditions under the Escrow
Agreement must be made by the Board of Directors of Sonus immediately
following the merger.

    Safe Harbor

    This press release contains forward-looking statements, including
statements concerning clinical trial results and the proposed merger between
Sonus and OncoGenex. 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. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. For example, statements of the results of clinical
studies, the timing of clinical trials and development efforts and the timing
of closing the proposed merger are all forward-looking statements. The
potential risks and uncertainties include, among others, that clinical results
will not be maintained in final data analysis, that current or future clinical
trials will not be successful or confirm the results of earlier studies, risks
related to the timing and costs of clinical trials and regulatory approvals,
risks associated with obtaining funding from third parties or completing a
financing necessary to support the costs and expenses of clinical studies,
risks relating to the development, safety and efficacy of therapeutic drugs
and potential applications for these products and the possibility that the
merger with Sonus does not close or that the closing may be delayed. No
assurances can be given that any of the events anticipated by the
forward-looking statements will transpire or occur, or if any of them do so,
what impact they will have on the results of operations or financial condition
of OncoGenex. The Company undertakes no obligation to update the
forward-looking statements contained herein or to reflect events or
circumstances occurring after the date hereof.

    Proxy Solicitation

    In connection with the proposed merger, Sonus filed with the SEC a Proxy
Statement and related materials on July 3, 2008 containing information about
Sonus, OncoGenex and the proposed merger. Sonus mailed the Proxy Statement to
its stockholders on or about July 9, 2008. INVESTORS AND SECURITY HOLDERS ARE
URGED TO READ THE PROXY STATEMENT AND THE OTHER RELEVANT MATERIALS, CAREFULLY
AND IN THEIR ENTIRETY, BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT SONUS,
ONCOGENEX AND THE PROPOSED MERGER.
    Sonus and OncoGenex, and certain of their directors, executive officers
and other members of management and employees may be deemed to be participants
in the solicitation of proxies in connection with the proposed transaction.
Information about the directors and executive officers of Sonus, including
their respective security holdings, is set forth in Sonus' Amendment No. 1 to
Form 10-K for the fiscal year ended December 31, 2007, filed with the
Securities and Exchange Commission on April 29, 2008, and the Proxy Statement
filed with the SEC on July 3, 2008. As of June 30, 2008, OncoGenex' directors
and executive officers beneficially owned approximately 1,755,000 shares, or
14.5%, of OncoGenex' capital stock. Investors may obtain additional
information regarding the interests of OncoGenex, Sonus and their respective
executive officers and directors in the merger by reading the Proxy Statement
for such proposed transaction.
    The Proxy Statement and other relevant materials, and any other documents
filed by Sonus with the SEC, may be obtained free of charge at the SEC's web
site at www.sec.gov. In addition, investors and security holders may obtain
free copies of the documents filed with the SEC by Sonus by directing a
request to: Sonus Pharmaceuticals, Inc., 1522 217th Place SE, Suite 100,
Bothell, WA 98021, Phone (425) 686-1500, Fax (425) 686-1600, Attention:
Investor Relations.





For further information:

For further information: OncoGenex Media and Investor Contact: Jason I.
Spark, Porter Novelli Life Sciences, (619) 849-6005,
jspark@pnlifesciences.com

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ONCOGENEX TECHNOLOGIES INC.

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