BOTHELL, WA and VANCOUVER, May 14 /CNW/ - OncoGenex Pharmaceuticals, Inc.
(NASDAQ: OGXI) today announced the release of two abstracts to be presented
during oral presentations at the upcoming American Society of Clinical
Oncology (ASCO) Annual Meeting. Abstracts are now available to the public
online on the OncoGenex Web site at www.oncogenex.com in addition to the ASCO
Web site, www.abstract.asco.org.
Highlights from the OGX-011 Abstract
At the time data was submitted to ASCO and as previously disclosed in
December 2008, the preliminary median overall survival in patients with
advanced prostate cancer who were treated with OGX-011 plus docetaxel in a
randomized Phase 2 trial was 27.5 months compared to 16.9 months for patients
treated with docetaxel alone. The hazard ratio (HR), a measure used to
determine the difference in survival between treatment groups, was 0.60,
representing a 40% reduction in the rate of death for patients treated with
OGX-011. New data disclosed today include a prospectively defined multivariate
analysis evaluating variables predictive of overall survival. The analysis
defined only three variables predictive of overall survival: performance
status, presence of visceral metastasis and assignment to the OGX-011
treatment arm. Based on the multivariate analysis, patients treated with
OGX-011 had a rate of death 46% lower than patients treated with docetaxel
alone (HR=0.54; p=0.04).
The abstract represents survival data as of November 2008. Final survival
data as of April 2009 for this trial will be presented during an oral
presentation at ASCO.
Highlights from the OGX-427 Abstract
At the time the data was submitted to ASCO, 34 patients with a variety of
cancers had been treated with OGX-427 as a single agent in a dose escalation
Phase 1 trial. OGX-427 was well tolerated. Declines in circulating tumor cells
(CTCs), an emerging metric to assess treatment effect, have been observed at
all dose levels. Changes in tumor markers (i.e declines of PSA, CA-125) have
also been observed. Reductions in CTCs and tumor markers both suggest
The abstract represents preliminary data on OGX-427 as a single agent.
Updated data will be presented during an oral presentation at ASCO.
The oral presentations are scheduled to be held as shown below at the
ASCO Annual Meeting in Orlando, Florida.
Title: Mature results of a randomized phase II study of OGX-011 in
combination with docetaxel/prednisone versus
docetaxel/prednisone in patients with metastatic castration
resistant prostate cancer
Authors: K. N. Chi, S. J. Hotte, E. Yu, D. Tu, B. Eigl, I. Tannock, F.
Saad, S. North, J. Powers, E. Eisenhauer, National Cancer
Institute of Canada Clinical Trials Group
Date: 4:30 p.m. - 4:45 p.m. EDT, Saturday, May 30, 2009
Location: Level 3, Chapin Theatre, W320, Orange County Convention Center
Abstract: No. 5012
Title: OGX-427, a 2'methoxyethyl antisense oligonucleotide (ASO),
against HSP27: Results of a first-in-human trial
Authors: S. J. Hotte, E. Y. Yu, H. W. Hirte, C. S.Higano, M. Gleave, K.
Date: 2:00 p.m. - 2:15 p.m. EDT, Saturday, May 30, 2009
Location: Level 4, Valencia Room, W415A, Orange County Convention Center
Abstract: No. 3506
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 2008 Annual Meeting of the American Society of Clinical Oncology,
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.
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
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 a Phase 1 clinical trial for the treatment of solid
tumors including prostate, non-small cell lung, breast, ovarian, and bladder
cancers. Like OGX-011, this product candidate has potential as a treatment in
a broad number of cancers.
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 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 agreement in respect of OGX-011 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.
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 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.
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 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.
For further information:
For further information: OncoGenex Contact: Scott Cormack, President &
CEO, (604) 736-3678, firstname.lastname@example.org; Media and Investor Contact: Jason
Spark, Porter Novelli Life Sciences, (619) 849-6005,