Exhibit 99.1
OncoGenex Pharmaceuticals Announces OGX-011 Treatment Provides Survival
Benefit in Randomized Phase 2 Trial in Advanced Metastatic Prostate Cancer
Webcast at 7:10 p.m. Eastern Time Today
BOTHELL, WA, and VANCOUVER, May 30, 2009 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today
announced the final results of a Randomized Phase 2 Trial presented during an oral presentation at
the American Society of Clinical Oncology (ASCO) Annual Meeting. Analyses indicated a survival
benefit in patients treated with OGX-011 in combination with docetaxel compared to docetaxel alone
the current standard care for patients with advanced prostate cancer:
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The median overall survival in patients with advanced metastatic prostate cancer who
were treated with OGX-011 plus docetaxel in a randomized Phase 2 trial was 23.8 months
compared to 16.9 months for patients treated with docetaxel alone a 6.9 month observed
survival advantage for the OGX-011 arm. |
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The unadjusted hazard ratio (HR), a measure used to compare the death rates between
treatment groups, was 0.61, representing a 39% lower rate of death for patients treated
with OGX-011. |
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A prospectively defined multivariate analysis indicated that the significant
predictors of overall survival were treatment arm, performance status, and presence of
metastases other than in bone or lymph nodes. Patients treated with OGX-011 had a rate of
death 51% lower than patients treated with docetaxel alone (HR=0.49; p=0.012). Additional
exploratory analyses found that the lower rate of death was associated with the effect of
OGX-011 treatment even when varying amounts of chemotherapy were administered (i.e.
OGX-011 treatment resulted in a lower rate of death when compared to the control arm for
patients receiving 6 or less cycles of chemotherapy as well as for patients receiving 10
cycles of chemotherapy). |
Data were presented by Dr. Kim Nguyen Chi, Principal Investigator and a medical oncologist at BC
Cancer Agency Vancouver Centre, representing the NCIC Clinical Trials Group (NCIC-CTG). The
survival curves presented by Dr. Chi are available at www.oncogenex.com.
A 6.9 month median overall survival difference would represent a significant improvement over the
current standard docetaxel therapy, said Dr. Chi, Principal Investigator of the NCIC-CTG sponsored
trial and presenter of the data at ASCO. Docetaxel was approved in 2004 based on a 2.4 month
survival advantage in advanced prostate cancer. The consistent results in favor of the OGX-011
treatment arm in this trial are a clear indication that Phase 3 trials are warranted.
A 39% reduction in death, consistent with the previously disclosed preliminary analysis, would be
a significant advancement for treatment in this patient population, said Scott Cormack, president
and CEO of OncoGenex. The multivariate analysis shows an even greater reduction in death rate
than our preliminary data and increases our confidence that we are seeing a real and meaningful
survival benefit for patients treated with OGX-011 in this Phase 2 study.
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About the Randomized Phase 2 Trial and the Trial Results
The trial enrolled 82 patients at 12 sites in Canada and the U.S. from September 2005 to December
2006. Patients were randomized to one of two treatment arms to receive either 640 mg per week of
OGX-011 by intravenous infusion in combination with docetaxel and prednisone or docetaxel and
prednisone alone. Patients in both treatment arms receive therapy until disease progression,
toxicity or after receiving ten 3-week cycles of therapy. The primary endpoint of the trial was to
achieve a 50% reduction in PSA from baseline in over 50% of the patients treated with OGX-011 plus
docetaxel. Secondary endpoints included determining objective response and duration of response in
those patients with measurable disease at baseline, determining the tolerability and toxicity of
weekly OGX-011 and docetaxel when administered in combination, measuring the effect of OGX-011 plus
docetaxel or docetaxel alone on serum clusterin levels and describing time to progression and
overall patient survival. Baseline characteristics were well balanced between the treatment arms.
In addition to the survival results presented and based on a median follow-up of 32 months, data
were presented as summarized below.
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The OGX-011 plus docetaxel arm met the primary endpoint of the trial given that 58% of
patients treated with OGX-011 plus docetaxel achieved confirmed PSA declines of 50% or
greater. |
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The median number of treatment cycles administered was 9 cycles in the OGX-011 plus
docetaxel arm compared to 7 cycles in the docetaxel arm. The majority of patients either
completed all 10 cycles of trial treatment (34 patients) or discontinued trial treatment
based on disease progression (23 patients) or adverse events (14 patients). |
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Fewer than half as many patients in the OGX-011 plus docetaxel arm (7 patients)
discontinued trial treatment early for PSA progression and/or objective disease
progression compared to the docetaxel arm (16 patients). Of the 9 patients in the OGX-011
arm that discontinued for adverse events, 7 of these patients experienced adverse events
during the 8th and 9th treatment cycles. |
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Evidence of a pharmacodynamic effect in the OGX-011 plus docetaxel arm was observed
with statistically significant declines in serum clusterin levels within the first cycle
of trial treatment when compared to levels in the docetaxel arm. OGX-011 has been shown to
primarily target tissue clusterin levels with serum levels as an indicator of biological
effect. |
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Higher incidence of stable disease (20 patients in OGX-011 plus docetaxel arm versus 12
patients in docetaxel arm) with lower incidence of disease progression as best response (1
patient in OGX-011 plus docetaxel arm versus 4 patients in docetaxel arm) occurred in
patients with measurable disease who were treated with OGX-011 plus docetaxel compared to
the docetaxel arm; although, the incidence of overall response was comparable. |
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OGX-011 treatment was well tolerated in combination with docetaxel. There was an increase in
incidence of mild fever, chills and creatinine levels (a laboratory measure for reduced kidney
function) and a moderate to significant decrease in circulating lymphocytes in the blood (another
laboratory measure) without any increase in infection rate compared to the docetaxel arm. The
investigators concluded that the combination was well tolerated.
Brent Blumenstein, an independent statistician who conducted additional sensitivity analyses of the
results, found that the survival benefit in the OGX-011 arm to be robust and not dependent on
clinical trial sites or baseline characteristics of the patients.
There is a clear separation of the survival curves, said Blumenstein. A hazard ratio of 0.61
indicates a distinct difference in survival rates and fully justifies further Phase 3 trials. It is
rare for a new intervention at this stage of development to have such strong data from a randomized
clinical trial.
Cormack added, These data clearly justify advancing to Phase 3 development, and we expect these
data will be key in our partnering discussions for future clinical development and potential
commercialization.
The trial was supported by funding from the Canadian Cancer Society and was conducted by the NCIC
Clinical Trials Group (NCIC CTG) based at Queens University in Kingston, Ontario. The trial was
further supported by an unrestricted grant from Sanofi-Aventis.
Webcast and Conference Call Today
OncoGenex will hold a live webcast and conference call of presentations made at a Company hosted
reception during the 2009 American Society of Clinical Oncology Annual Meeting (ASCO) today, May
30, 2009. The webcast will begin at 7:10 p.m. EDT.
During the reception, OncoGenex management and guest speakers will provide a comprehensive review
of the final results of the randomized Phase 2 trial presented at the ASCO Annual Meeting, as well
as discuss the treatment landscape and the relevance of clinical trial endpoints for prostate
cancer.
To access the webcast, log on to the Investor Relations page of the OncoGenex Web site at
www.oncogenex.com. Alternatively, you may access the live conference call by dialing 877-627-6544
(U.S. & Canada) or 719-325-4857 (International). A webcast replay will be available approximately
two hours after the call and will be archived at www.oncogenex.com.
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 trials in
prostate, lung and breast cancer. At the 2009 American Urological Association Annual Meeting,
OncoGenex reported Phase 2 data with OGX-011 in combination with second-line treatment of
metastatic castrate resistant prostate cancer showing better than expected survival results,
reductions in levels of clusterin, durable reductions in pain, and a decline in PSA, a protein that
is often elevated in patients with prostate cancer.
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Based on clinical results to date, OncoGenex intends to conduct Phase 3 registration trials 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 two Phase 3
registration trials, via the Special Protocol Assessment (SPA) process, of OGX-011 in combination
with second-line chemotherapy. One trial design investigates overall survival as the primary
endpoint; the other trial design investigates pain palliation as the primary endpoint. Based on the
survival benefit observed after combining OGX-011 with first-line docetaxel chemotherapy, OncoGenex
has initiated discussions with the FDA regarding evaluating the overall survival benefit in
patients treated with first-line chemotherapy, rather than second-line chemotherapy. OGX-011 has received Fast Track designation from the FDA for the treatment of progressive
metastatic prostate cancer in combination with docetaxel.
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 currently completing
five Phase 2 clinical trials 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 OncoGenex.
More information about OncoGenex 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 managements 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.
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The potential risks and uncertainties associated with forward-looking statements 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 Companys filings with the Securities and Exchange Commission, including the Companys 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.
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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