Exhibit 99.1
OncoGenex Announces that a Randomized, Investigator-Sponsored Phase 2 Study Evaluating OGX-427
has Received Grant Funding
BOTHELL, WA and VANCOUVER, BCJanuary 6, 2010 OncoGenex Pharmaceuticals, Inc. (NASDAQ:
OGXI), today announced that a randomized, controlled, investigator-sponsored Phase 2
clinical trial evaluating OGX-427 when administered as a monotherapy to patients with
castrate resistant prostate cancer (CRPC) has received grant funding. The funds were awarded
by a third party granting agency to Dr. Kim Chi, a medical oncologist at the BC Cancer
Agency, Research Scientist at the Vancouver Prostate Centre and the principal investigator
of the OGX-427 Phase 2 trial.
The randomized, controlled Phase 2 study will enroll up to 72 patients and is designed to
determine the potential benefit of OGX-427 by evaluating the number of patients who are
without disease progression at 12 weeks post study treatment with or without OGX-427. This
Phase 2 trial will also measure the direct effect of OGX-427 on PSA levels, time to
progression by PSA or measurable disease, numbers of circulating tumor cells (CTCs) and
other relevant secondary endpoints. The trial is expected to start by mid 2010 following
final analysis of Phase 1 data and approval by Health Canada and the institutional review
board. As previously reported, a Phase 1 trial of OGX-427 administered systemically as a
single agent to patients with various solid tumors showed reductions in tumor markers
associated with prostate and ovarian cancer as well as reductions in total circulating tumor
cells.
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 treatment-induced cell death
through multiple pathways, including the androgen receptor (AR). Preclinical studies have
shown that androgen bound to the AR on prostate tumor cells induces rapid Hsp27
phosphorylation that in turn enhances AR activity and prostate cancer cell survival.
OGX-427-induced knockdown of Hsp27 led to AR degradation, decreased PSA levels, and delayed
progression of castration resistant prostate tumors.
The results from our Phase 1 program supports the development of OGX-427 in a number of
solid tumors. This grant-funded Phase 2 trial in prostate cancer complements a separate
ongoing clinical investigation of OGX-427 in bladder cancer funded by the National Cancer
Institute of Canada. We are also considering a randomized Phase 2 clinical trial
investigating OGX-427 in ovarian cancer, said Scott Cormack, President and Chief Executive
Officer of OncoGenex. The OGX-427 trials in prostate and bladder cancer are consistent with
our strategy to advance our pipeline with minimal impact on our burn rate.
The reduction in circulating tumor cells and tumor markers seen during a previously
reported Phase 1 study of OGX-427 administered as a single agent has been very encouraging,
said Dr. Kim Chi. Given the well-tolerated safety profile for OGX-427 and the limited
number of proven systemic therapeutic options for CRPC, demonstration of clinical benefit
for single-agent OGX-427 would be an important alternative therapy for patients.
This Phase 2 trial of OGX-427 is designed to confirm the pre-clinical observations that
OGX-427 inhibits multiple Hsp27-regulated pathways that enhance prostate tumor cell
survival, said Dr. Martin Gleave, Chief Scientific Officer at OncoGenex, and Distinguished
Professor of Urologic Sciences at University of British Columbia. Targeting Hsp27 as a
therapy is attractive as it suppresses many pathways implicated in cancer progression and
resistance, including the AR which is of critical importance in CRPC, as opposed to
targeting of a single pathway which might be expected to have limited benefits.
About OGX-427
OGX-427 is designed to reduce levels 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.
In August 2009, OncoGenex announced the first patient 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. 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).
OGX-427 is also being evaluated in a separate Phase 1 clinical trial for the systemic
(intravenous) treatment of solid tumors including prostate, non-small cell lung, breast,
ovarian, and bladder cancers. OncoGenex 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 most 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 suggest single-agent
activity warranting further clinical investigation.
About OncoGenex Pharmaceuticals
OncoGenex is a biopharmaceutical company committed to the development and commercialization
of new cancer therapies that address treatment resistance in cancer patients. 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. OncoGenex and Teva
Pharmaceutical have entered a global collaboration and license agreement to develop and
commercialize OncoGenexs lead drug candidate, OGX-011. The companies expect to initiate two
Phase 3 trials in castrate resistant prostate cancer in 2010, and a third Phase 3 trial in
non-small cell lung cancer in early 2011; OGX-427 is in Phase 1 clinical development; SN2310
has completed a 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 target and inhibit production of specific proteins
which OncoGenex believes are important in tumor progression and treatment resistance. 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.
OncoGenex 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 anticipated clinical and other product development
activities and timing and costs of these activities. 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. All statements other than statements of
historical fact are statements that could be deemed forward-looking statements. Such
forward-looking statements are subject to risks and uncertainties, including, among others,
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, other than as may be
required by applicable law.
More information about OncoGenex is available at www.oncogenex.com.
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OncoGenex Contact:
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Media and Investor Contact: |
Scott Cormack
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Jason Spark |
President & CEO
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Porter Novelli Life Sciences |
(604) 630-5400
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(619) 849-6005 |
scormack@oncogenex.com
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jspark@pnlifesciences.com |