OncoGenex Announces Fast Track Designation Granted for Custirsen in
Combination with Cabazitaxel/Prednisone as Second-line Chemotherapy in Phase 3
AFFINITY Trial of Men with Metastatic Castrate-Resistant Prostate Cancer
Third Phase 3 Trial of Custirsen to Receive FDA Fast Track Designation
BOTHELL, Wash. and VANCOUVER, British Columbia, April 23, 2014 /CNW/ -
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced that the U.S.
Food and Drug Administration (FDA) has granted Fast Track designation to the
investigation of custirsen when administered in combination with
cabazitaxel/prednisone for the treatment of men with metastatic
castrate-resistant prostate cancer (CRPC) following prior treatment with a
Fast track is a process designed to facilitate the development, and expedite
the review, of drugs to treat serious conditions and fill an unmet medical
need. The purpose is to get important new drugs to the patient earlier.
The international, randomized, open-label Phase 3 AFFINITY trial is designed
to evaluate if custirsen, when combined with second-line chemotherapy
cabazitaxel and prednisone, has the potential to improve survival outcomes for
prostate cancer patients compared to second-line chemotherapy alone. AFFINITY
will enroll approximately 630 men and is expected to complete enrollment in
the second half of 2014.
Custirsen has also received Fast Track designation from the FDA for treatment
of patients with metastatic non-small cell lung cancer as part of the Phase 3
ENSPIRIT trial and for men with metastatic CRPC as part of the Phase 3 SYNERGY
trial. Enrollment in the ENSPIRIT trial is ongoing and top-line survival
results from SYNERGY are expected by mid-2014.
For more information on the AFFINITY trial, including centers currently
enrolling patients, please visit www.prostatecancerstudy.com.
About Custirsen Custirsen is an experimental drug that is designed to block
the production of the protein clusterin, which may play a fundamental role in
cancer cell survival and treatment resistance. Clusterin is upregulated in
tumor cells in response to treatment interventions such as chemotherapy,
hormone ablation and radiation therapy and has been found to be overexpressed
in a number of cancers, including prostate, lung, breast and bladder.
Increased clusterin production has been linked to faster rates of cancer
progression, treatment resistance and shorter survival duration. By inhibiting
clusterin, custirsen is designed to alter tumor dynamics, slowing tumor growth
and resistance to partner treatments, so that the benefits of therapy,
including survival, may be extended.
As part of Phase 1 and Phase 2 clinical trials, custirsen was administered to
294 patients with various types of cancer. The majority of adverse events were
mild. The most common adverse events associated with custirsen consisted of
flu-like symptoms. The most common serious adverse events (SAE) associated
with custirsen were febrile neutropenia, fever, pleural effusion, and dyspnea.
Each SAE event was observed in approximately 2%-4% of patients.
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. OncoGenex and Teva
Pharmaceutical Industries Ltd. (NYSE: TEVA) have entered a global
collaboration and licensing agreement to develop and commercialize OncoGenex'
lead drug candidate, custirsen. Custirsen is currently in Phase 3 clinical
development as a treatment in men with metastatic castrate-resistant prostate
cancer and in patients with advanced, unresectable non-small cell lung cancer.
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 concerning the potential regulatory timelines and the
potential market opportunity for our product candidates. 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, including, among others,
the risk that our product candidates will not receive regulatory approval as
or when expected, the risk that our product candidates will not successfully
be commercialized 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.
SOURCE OncoGenex Pharmaceuticals, Inc.
Media: Jaime Welch, firstname.lastname@example.org, 604-630-5403; or Investor Relations:
Susan Specht, email@example.com, 425-686-1535
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CO: OncoGenex Pharmaceuticals, Inc.
ST: British Columbia
NI: HEA MTC BTC
-0- Apr/23/2014 10:01 GMT
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