OncoGenex Expands Clinical Development of OGX-427 with a Phase 1 Clinical Trial in Bladder Cancer

    BOTHELL, WA and VANCOUVER, Aug. 13 /CNW/ - OncoGenex Pharmaceuticals,
Inc. (NASDAQ:   OGXI), today announced that the first patient has been dosed in
an open label, dose-escalation, Phase 1 clinical trial evaluating OGX-427 when
administered directly into the bladder in patients with bladder cancer. This
trial is separate from an ongoing Phase 1 trial of OGX-427 administered
systemically in patients with various solid tumors. OGX-427 is a
second-generation antisense drug that is designed to reduce production of Heat
Shock Protein 27 (Hsp27), a cell-survival protein that inhibits apoptotic cell
death through multiple pathways.
    The study, which will enroll up to 36 patients with bladder cancer, is
designed to determine the safety and potential benefit of OGX-427 administered
directly into the bladder using a catheter, which is called intravesical
instillation. In addition, the study will measure the direct effect of OGX-427
on expression of Hsp27 in bladder tumor cells as well as determine the
pharmacokinetics and pharmacodynamics of OGX-427 when delivered by
intravesical instillation. The study is sponsored by the National Cancer
Institute of Canada (NCIC). Dr. Alan So, an Assistant Professor in the
Department of Urologic Sciences at the University of British Columbia and
Research Scientist at the Vancouver Prostate Centre, is the study's principal
    "The current treatment for superficial bladder cancer is local resection
with immunotherapy, which often has significant local and systemic side
effects," said Dr. So. "Because of the limitations of current adjuvant
options, a treatment option like intravesical delivery of OGX-427 that is
specifically targeted to the tumor would be desirable."
    "This Phase 1 trial of OGX-427 is an attractive trial design as removal
of bladder tumor samples after treatment allows us to demonstrate inhibition
of Hsp27 expression at the cellular level in the tumor," said Scott Cormack,
President and Chief Executive Officer of OncoGenex.
    "By conducting this trial through an investigator-sponsored trial with
leading clinical researchers at the Vancouver Prostate Centre allows us to
advance the development of OGX-427 without a significant commitment of our
financial resources," Cormack added.
    In preclinical studies conducted by the Vancouver Prostate Centre,
OGX-427 had single-agent activity in multiple cancers. In preclinical models
of bladder cancer, the investigators observed that bladder cancer tumors were
significantly smaller six weeks after OGX-427 administration compared to the
control group.

    About OGX-427

    OGX-427 is designed to reduce production of Hsp27, a protein that is
over-produced in response to many cancer treatments including hormone ablation
therapy, chemotherapy and radiation therapy. Hsp27 production has been shown
to inhibit cell death in tumor cells through a variety of mechanisms.
    OGX-427 is being evaluated in another Phase 1 clinical trial for the
systemic (intravenous) treatment of solid tumors including prostate, non-small
cell lung, breast, ovarian, and bladder cancers. OncoGenex Pharmaceuticals,
Inc. recently announced preliminary results of this Phase 1 trial presented
during an oral presentation at the 2009 American Society of Clinical Oncology
(ASCO) Annual Meeting. Results as of May 2009 showed that OGX-427 was well
tolerated as a monotherapy. In addition, after treatment with OGX-427 patients
experienced declines in circulating tumor cells at all doses evaluated as well
as evidence of reduction in tumor markers. Reductions in circulating tumor
cells and tumor markers both suggest single-agent activity warranting further
clinical investigation.
    Similar to OGX-011, OGX-427 has potential as a treatment in a broad
number of cancers.

    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 studies 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
    More information about OncoGenex is available at www.oncogenex.com.

    Forward Looking Statements

    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, but not limited to, statements concerning the
potential activity and clinical benefit of OGX-427 and the anticipated
clinical development activities and timing of these activities. Such
forward-looking statements are subject to risks and uncertainties, including,
among others: 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, other than as may be required
by applicable law.

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,

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