OncoGenex Achieves Key Regulatory Milestone for Lead Product Candidate, OGX-011



    
    FDA confirms appropriateness of durable pain palliation as a primary
                   endpoint for product marketing approval

         Milestone achievement results in release of escrowed shares
    

    BOTHELL, WA and VANCOUVER, Oct. 13 /CNW/ - OncoGenex Pharmaceuticals Inc.
(NASDAQ:   OGXI) today announced that it concluded a meeting with the U.S. Food
and Drug Administration (FDA) on October 7, 2008, and that the FDA agreed that
"durable pain palliation is an acceptable and desirable study endpoint" to
support a product marketing approval for OGX-011 as a treatment for hormone
refractory prostate cancer (HRPC). In addition, OncoGenex reported that the
FDA provided guidance on the submitted protocol including recommendations on
study endpoints, the appropriate patient population, entry criteria and study
conduct. The company plans to revise and submit the protocol for completing a
Special Protocol Assessment with the FDA prior to initiating the registration
trial.
    Based on the results of this meeting, the Board of Directors of OncoGenex
Pharmaceuticals has approved the release of 25% (347,207) of the shares held
in escrow pursuant to agreements related to Sonus Pharmaceuticals' merger with
OncoGenex Technologies described in its Proxy Statement filed with the SEC on
July 3, 2008. The escrow agreements provided for the release of 25% of the
shares held in escrow following the occurrence of a meeting with the FDA to
confirm that pain palliation is an appropriate primary endpoint to support a
product marketing approval in prostate cancer. A total of 694,431 milestone
shares remain in escrow.
    "Our data combining OGX-011 with second line chemotherapy in patients
with HRPC has shown potential improvement in both pain palliation and
survival. On July 14, 2008, OncoGenex announced that the company successfully
completed an SPA with the FDA on the design of another Phase 3 registration
trial of OGX-011 targeting overall survival as a primary endpoint for the
treatment of HRPC," said Scott Cormack, President and CEO of OncoGenex
Pharmaceuticals. "Obtaining FDA's agreement that pain palliation is an
appropriate primary endpoint to support product approval in prostate cancer
and receiving FDA's guidance on trial designs is essential to our plans to
pursue development of OGX-011 using appropriate primary endpoints such as pain
palliation and survival."
    This planned registration trial to evaluate pain palliation is based on
encouraging preliminary data from a Phase 2 study in HRPC indicating that
OGX-011 treatment may result in durable pain palliation. These Phase 2 data
were presented at the 2008 annual meeting of the American Society of Clinical
Oncology (ASCO) and reported in a previous press release on June 2, 2008. In
summary, the Phase 2 study included 42 patients with HRPC who had received
first-line docetaxel therapy and required second-line chemotherapy. While
follow up on surviving patients is still ongoing, preliminary findings related
to pain palliation reported reductions in pain or analgesic use in
approximately 50% of evaluable patients treated with either mitoxantrone plus
OGX-011 or retreated with docetaxel plus OGX-011. These data are better than
expected when compared to the 22-35% of patients receiving first-line
chemotherapy who reported a reduction in pain in the primary Phase 3 study
resulting in the approval of docetaxel (TAX 327 study) that was published in
the October 7th, 2004 issue of the New England Journal of Medicine.

    About OGX-011

    OGX-011, also known as custirsen sodium, 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. OGX-011 is being evaluated in five Phase 2 clinical trials,
each of which has completed patient enrollment. Interim study results have
previously been presented for each of the five clinical trials.

    About OncoGenex Pharmaceuticals

    OncoGenex Pharmaceuticals is a biopharmaceutical company committed to the
development and commercialization of new cancer 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
currently completing five Phase 2 clinical studies in prostate, lung and
breast cancers, is designed to inhibit the production of a specific protein
associated with treatment resistance; OGX-427 and SN2310 are in Phase 1
clinical development; and CSP-9222 and OGX-225 are currently in pre-clinical
development. More information 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 agreements with the FDA regarding
endpoints and clinical trial design and anticipated clinical and other product
development activities and timing of these activities. 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
Company's ability to gain FDA agreement on protocol design and time frames to
do so, the strength of the combined oncology product pipeline, the timing of
clinical trials and development efforts and the results of clinical and
pre-clinical studies are all forward-looking statements. The potential risks
and uncertainties include, among others, the possibility that an agreement
with FDA cannot be reached regarding a clinical trial using pain as the
primary endpoint for OGX-011, the timing and costs of clinical trials and
regulatory approvals, risks that clinical trials will not be successful or
confirm earlier clinical trial results, risks associated with obtaining
funding from third parties or completing a financing necessary to support the
costs and expenses of clinical studies as well as research and development
activities, as well as other risks relating to the development, safety and
efficacy of therapeutic drugs and potential applications for these products. A
more complete discussion of risks and uncertainties that may affect
forward-looking statements is included in the Company's filings with the
Securities and Exchange Commission, including its Annual Report on Form 10-K
for fiscal year 2007, and its Quarterly Report on Form 10-Q for the second
quarter of 2008. 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 the Company. 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) 630-5400, scormack@oncogenex.com; Media and Investor Contact: Megan
Lavine, Porter Novelli Life Sciences, (619) 849-5388,
mlavine@pnlifesciences.com


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