BOTHELL, Wash. and VANCOUVER, British Columbia, Aug. 16, 2016 /PRNewswire/ -- OncoGenex
Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today results from
the final analysis of AFFINITY, the Phase 3 trial of custirsen in
men with metastatic castrate-resistant prostate cancer (CRPC) whose
disease has progressed after treatment with docetaxel. The trial
did not meet the primary endpoint of demonstrating a statistically
significant improvement in overall survival for patients treated
with custirsen in combination with cabazitaxel/prednisone compared
to cabazitaxel/prednisone alone.
The adverse events were consistent with those observed in
previous trials of custirsen in metastatic CRPC. The final data
will be submitted as a late-breaking abstract to the European
Society for Medical Oncology (ESMO) Annual Congress 2016.
"We are obviously disappointed that custirsen was unable to
demonstrate a survival benefit in prostate cancer. We would like to
thank the patients who participated in the AFFINITY trial and their
caregivers, as well as the investigators and their teams for their
commitment to improving cancer care for patients who are in
desperate need of new treatment options," said Scott Cormack, President and CEO of
OncoGenex.
As a result of these data and previous custirsen findings,
OncoGenex plans to initiate discussions with the U.S. Food and Drug
Administration (FDA) to evaluate options related to an early
analysis of the Phase 3 ENSPIRIT trial investigating custirsen in
combination with docetaxel as second-line chemotherapy in patients
with non-small cell lung cancer (NSCLC).
"Given that the ENSPIRIT trial has nearly completed enrollment
and we believe there are likely a sufficient number of events to
determine the effect of custirsen in NSCLC, we are eager to
expedite the final data analysis, which would allow us to conserve
resources and fully understand the value of the asset as we
evaluate our alternatives to maximize shareholder value," said
Cormack.
OncoGenex has engaged MTS Health Partners, LP as its advisor to
assist with the exploration of strategic alternatives.
Conference Call Details
OncoGenex will host a
conference call at 7:30 a.m. Eastern
Time today, Tuesday, August 16,
2016, to discuss today's news. A live event will be
available on the Investor Relations section of the OncoGenex
website at www.OncoGenex.com. Alternatively, visitors may access
the live conference call by dialing (877) 606-1416 (U.S. &
Canada) or (707) 287-9313
(International). A webcast replay will be available approximately
two hours after the call and will be archived
on www.OncoGenex.com for 90 days.
About the AFFINITY Trial
The Phase 3 AFFINITY
trial was an international, randomized, open-label study designed
to evaluate whether custirsen, when combined with cabazitaxel,
could improve survival outcomes for patients with metastatic CRPC
whose disease has progressed after treatment with docetaxel.
Patients received cabazitaxel in combination with weekly
custirsen or cabazitaxel alone, and treatment continued until
disease progression, unacceptable toxicity or completion of 10
cycles. The AFFINITY trial enrolled 634 men with metastatic CRPC at
95 sites throughout North America,
Europe, Russia and Australia. For more information on the
AFFINITY trial, please visit ClinicalTrials.gov (NCT01578655).
About ENSPIRIT Trial
The Phase 3 ENSPIRIT trial
is an international, randomized, open-label trial designed to
evaluate custirsen for the treatment of advanced or metastatic
NSCLC in 700 patients who have progressed after initial
chemotherapy treatment. The trial is investigating if combining
custirsen with docetaxel, a standard second-line NSCLC
chemotherapy, has the potential to improve survival outcomes
compared to docetaxel alone in these patients. ENSPIRIT is expected
to enroll patients at approximately 50 sites globally. For more
information on the ENSPIRIT trial, please visit ClincalTrials.gov
(NCT01630733).
About Custirsen
Custirsen is a highly specific
clusterin inhibitor designed to improve survival in patients with
advanced cancer by disabling a fundamental cellular repair
mechanism used by tumor cells. Custirsen binds to clusterin mRNA to
block the production of clusterin protein and has enhanced the
tumor cell destructive effects of multiple anti-cancer therapies
across a variety of tumor models. By inhibiting clusterin,
custirsen is designed to alter tumor dynamics by slowing tumor
growth and inhibiting tumor resistance to partner treatments, so
that the benefits of therapy, including survival, may be
extended.
About OncoGenex
OncoGenex is a biopharmaceutical
company committed to the development and commercialization of new
therapies that address treatment resistance in cancer patients.
OncoGenex has a diverse oncology pipeline, with each product
candidate having a distinct mechanism of action and representing a
unique opportunity for cancer drug development. Custirsen is
currently in Phase 3 clinical development as a treatment in
patients with advanced, unresectable NSCLC. Apatorsen is in Phase 2
clinical development and OGX-225 is currently in pre-clinical
development. More information is available at www.OncoGenex.com and
at the company's Twitter
account: https://twitter.com/OncoGenex_IR.
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
regarding the potential benefits and development of our product
candidates, potential modifications to clinical development plans
and business strategies. 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. Such risks and uncertainties include, among others, the
risk that our product candidates do not demonstrate the
hypothesized or expected benefits, the risk that our proposed
modifications to clinical development activities are not agreed on
by the FDA or do not result in the intended benefits, the risk that
we cannot achieve our business strategies, the risk that new
developments in the rapidly evolving cancer therapy landscape
require changes in our clinical trial plans or limit the potential
benefits of our product and the other factors described in our risk
factors set forth in our filings with the Securities and Exchange
Commission from time to time, including the Company's Annual Report
on Form 10-K and Quarterly Reports 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, other than as may be required by applicable
law.
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SOURCE OncoGenex Pharmaceuticals, Inc.