FDA Grants Fast Track Designation for OncoGenex Pharmaceuticals' Lead Product Candidate OGX-011



    BOTHELL, WA and VANCOUVER, Aug. 22 /CNW/ - OncoGenex Pharmaceuticals
(NASDAQ:   OGXI) announced today that OGX-011, also known as custirsen sodium,
received Fast Track designation from the U.S. Food & Drug Administration (FDA)
in combination with docetaxel for progressive metastatic prostate cancer.
OGX-011 is currently completing five Phase 2 clinical studies in prostate,
lung and breast cancer, and is designed to inhibit the production of a
specific protein, clusterin, associated with treatment resistance.
    Fast Track designation is granted to products that may provide a
significant improvement in the safety or effectiveness of the treatment for a
serious or life-threatening disease. Based on this designation, the FDA will
take actions as appropriate to expedite the development and review of OGX-011
for approval. These actions include scheduled meetings to obtain FDA input
into development plans, the option of submitting a New Drug Application in
sections rather than all components simultaneously, and the option of
requesting evaluation of studies using surrogate endpoints.
    "Obtaining Fast Track designation for custirsen sodium while developing
our Phase 3 program for hormone-refractory prostate cancer (HRPC) and in
advance of initiating our Phase 3 study is very important and should help us
move forward expeditiously on our pathway toward commercialization," said
Scott Cormack, chief executive officer of OncoGenex Pharmaceuticals. "We
welcome this designation as another example of our ability to rapidly advance
our development programs."
    The request for Fast Track designation was based on data from Phase 2
studies in HRPC as well as supporting data in non-small cell lung cancer
(NSCLC) indicating that OGX-011 treatment can significantly reduce serum
clusterin levels and that achieving low serum clusterin levels during
treatment is correlated with improved survival. Furthermore, serum clusterin
levels during OGX-011 treatment may be predictive of a treatment benefit with
OGX-011. In patients with HRPC who had failed first-line docetaxel while on or
within six months of first-line docetaxel therapy and received second-line
chemotherapy in combination with OGX-011 (Study OGX-011-07), achieving or
maintaining low serum clusterin levels correlated with improved survival.
Similar results were seen in Study OGX-011-05 in patients with NSCLC who were
treated with gemcitabine plus a platinum regimen and OGX-011. Data from the
Phase 2 study in HRPC were presented at the 2008 Annual Meeting of the
American Society of Clinical Oncology.

    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 specific proteins
associated with treatment resistance; OGX-427 and SN2310 are in Phase 1
clinical development; and CSP9222 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 Fast Track Designation for
OGX-011 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 expeditious review
attributed to Fast Track Designation, the Company's ability to rapidly advance
development programs, 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
Fast Track Designation will not expedite the development timing or the FDA
review of 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 first 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: Jason
Spark, Porter Novelli Life Sciences, (619) 849-6005,
jspark@pnlifesciences.com


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