OncoGenex Provides Update on Two-Year Survival Data from Ongoing Phase 1/2 Clinical Trial of OGX-011 in Non-Small Cell Lung Cancer



    BOTHELL, WA, and VANCOUVER, Feb. 4 /CNW/ - OncoGenex Pharmaceuticals,
Inc. (NASDAQ:   OGXI) today announced the two-year survival rate from a Phase
1/2 clinical trial of OGX-011 in combination with first-line chemotherapy for
the treatment of advanced non-small cell lung cancer (NSCLC). At two years,
30% of patients who had received OGX-011 with first-line chemotherapy were
alive. OncoGenex has previously reported a mature median survival of 14.1
months and a one-year survival rate of 54%.
    For comparison, published studies using a platinum-based regimen plus
gemcitabine as first-line chemotherapy for advanced NSCLC reported median
survivals of 8 to 11 months and one-year survival rates of 33% to 43%. Market
approval for Avastin plus paclitaxel and carboplatin chemotherapy for NSCLC
was based on results showing a median survival of 12.3 months compared to 10.3
months for patients treated with chemotherapy alone. Survival rates for
Avastin plus chemotherapy versus chemotherapy alone were reported as 51%
versus 44% at one year and 23% versus 15% at two years, respectively.
    "The two-year survival rate of 30% in our Phase 1/2 NSCLC study compares
favorably to the survival reported for Avastin plus paclitaxel and carboplatin
chemotherapy," said Scott Cormack, president and CEO of OncoGenex. "These data
remain consistent with our Phase 2 data in prostate cancer suggesting that
OGX-011 when added to chemotherapy may improve survival by blocking the
production of clusterin, the protein associated with treatment resistance in
various cancers."

    
    Non-Small Cell Lung Cancer Phase 1/2 Study Design with Updated Results as
    of January 23, 2009
    

    This single-arm, open-label study enrolled 81 patients with Stage IIIB
(18 percent) or Stage IV (82 percent) NSCLC who were treated with OGX-011 in
combination with a standard first-line NSCLC chemotherapy regimen that
included a platinum-based regimen plus gemcitabine. 51% of patients had
adenocarcinoma, 16% had squamous cell carcinoma and 33% of patients had
undifferentiated or unspecified non-small cell lung cancer. The primary
objectives of the study were designed to estimate objective response rates of
OGX-011 in combination with a gemcitabine/platinum-based regimen, establish
the recommended dose of OGX-011, and determine the safety and tolerability.
Secondary objectives were aimed to estimate the progression-free survival,
overall survival, the pharmacokinetic profile of OGX-011, and the effect of
OGX-011 on serum clusterin levels.

    
    -------------------------------------------------------------------------
    Median Follow-up                                  33 months
    Number of Patients Alive (follow up ongoing)      16/81 (20%)
    Median Overall Survival                           14.1 months (0.13-45.9)
    Number of Pts Surviving
              Greater than or equal to 12 months      54% (43%-64%: 95% CI)
              Greater than or equal to 18 months(1)   39% (28%-49%: 95% CI)
              Greater than or equal to 2 years(1)     30% (21%-40%: 95% CI)
    -------------------------------------------------------------------------
    (1) Kaplan-Meier Estimates
    

    69% of patients experienced disease control (complete response =1%,
partial response =30%, stable disease =38%), 26% experienced disease
progression, and response was not assessable in 5%. Median progression-free
survival was 4.6 months (0.06 - 17.7 months). Investigators concluded that the
treatment with OGX-011 was generally well tolerated, and toxicities were
consistent with the adverse event profile for gemcitabine in combination with
a platinum-based regimen in this population.
    Serum clusterin analysis for this NSCLC study showed that OGX-011
treatment significantly decreased the mean average serum clusterin levels
during treatment when compared to baseline levels (p (less than) 0.0001) and
that achieving low average serum clusterin levels during treatment correlated
with improved survival (p=0.012).

    About OGX-011

    OGX-011 is designed to inhibit the production of clusterin, a protein
that is associated with cancer treatment resistance and is currently being
evaluated in Phase 2 clinical studies in prostate, lung and breast cancer.
Recently, OncoGenex Pharmaceuticals announced that OGX-011 showed an overall
survival advantage in a randomized, controlled Phase 2 Study in first-line
treatment of metastatic castrate resistant prostate cancer, in which the
median survival for patients receiving OGX-011 in combination with docetaxel
and prednisone was 27.5 months, compared to 16.9 months in patients receiving
docetaxel and prednisone alone. At the 2008 Annual Meeting of the American
Society of Clinical Oncology meeting, OncoGenex reported OGX-011 Phase 2 data
in second-line treatment of metastatic castrate resistant prostate cancer
showing better than expected survival results in combination with
chemotherapy, reduction in levels of clusterin, durable reductions in pain,
and a decline in PSA, a protein that is often elevated in patients with
prostate cancer.
    Based on clinical results to date, OncoGenex intends to conduct Phase 3
registration studies with OGX-011 in metastatic castrate resistant prostate
cancer, subject to the receipt of additional funding. The U.S. Food & Drug
Administration (FDA) has agreed on the design of one Phase 3 registration
trial in combination with second-line chemotherapy investigating overall
survival as the primary endpoint via the Special Protocol Assessment (SPA)
process. In addition, the FDA has confirmed that durable pain palliation is an
acceptable primary endpoint for a registration trial in metastatic castrate
resistant prostate cancer. OncoGenex intends to obtain an agreement with FDA
on the design of a second Phase 3 registration trial featuring pain palliation
via the SPA process. OGX-011 has received Fast Track designation from the FDA
for the treatment of progressive metastatic prostate cancer in combination
with docetaxel.
    OncoGenex holds an exclusive license for patents related to clusterin
inhibition obtained from the University of British Columbia based on
discoveries made by researchers at the Prostate Centre at Vancouver General
Hospital. OGX-011 utilizes second generation antisense technology, licensed
from Isis Pharmaceuticals (NASDAQ:   ISIS), to effectively target and inhibit
production of clusterin protein in tumor cells. OncoGenex and Isis partnered
in the successful discovery and initial development of OGX-011 and, in 2008,
amended their agreement to provide OncoGenex with sole rights to OGX-011 and
sole responsibility for development costs and partnering decisions, subject to
financial obligations to Isis.

    About OncoGenex Pharmaceuticals

    OncoGenex Pharmaceuticals 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
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 is in Phase 1 clinical
development; SN2310 has completed enrollment in a Phase 1 clinical trial; 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 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. These risks and uncertainties
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 its Annual Report on Form 10-K
for fiscal year 2007 and its most recently filed Quarterly Report on Form
10-Q. 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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