OncoGenex Announces Top-Line Survival Results of Phase 3 SYNERGY Trial Evaluatin...
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`April 28, 2014
`OncoGenex Announces Top-Line Survival Results of Phase 3 SYNERGY
`Trial Evaluating Custirsen for Metastatic Castrate-Resistant Prostate Cancer
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`BOTHELL, Wash. and VANCOUVER, British Columbia, April 28, 2014 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today
`announced results from the Phase 3 SYNERGY trial. Top-line survival results indicate that the addition of custirsen to standard first-line
`docetaxel/prednisone therapy did not meet the primary endpoint of a statistically significant improvement in overall survival in men with
`metastatic castrate-resistant prostate cancer (CRPC), compared to docetaxel/prednisone alone (median survival 23.4 months vs 22.2 months,
`respectively; hazard ratio 0.93 and one-sided p value 0.207). The adverse events observed were similar to custirsen's known adverse event
`profile.
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`"The results of SYNERGY are unexpected, particularly given the wealth of scientific evidence supporting the targeting of clusterin to combat
`treatment resistance in first-line prostate cancer," said Scott Cormack, President and CEO of OncoGenex. "A thorough analysis of the data is
`underway to understand the potential factors that may have contributed to the results. Importantly, we remain strong in our belief that targeting
`mechanisms of treatment resistance is a critical path forward in the fight against cancer and we continue to actively pursue this approach
`through the two ongoing Phase 3 trials of custirsen and the seven Phase 2 trials of apatorsen in four tumor types. We would like to thank the
`men who participated in the SYNERGY trial and the friends and families who supported them."
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`OncoGenex will host a conference call and live webcast at 7:30 a.m. ET this morning.
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`To access the webcast, log on to the Investor Relations page of the OncoGenex website at www.oncogenex.com. Alternatively, you may access
`the live conference call by dialing (877) 606-1416 (U.S. & Canada) or (707) 287-9313 (International).
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`A webcast replay will be available approximately two hours after the call and will be archived on www.oncogenex.com for 90 days.
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`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.
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`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.
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`About SYNERGY
`The SYNERGY trial enrolled 1,022 men with mCRPC at more than 130 cancer centers throughout North America, Europe, Israel and South Korea.
`In the investigational arm of the trial, custirsen was administered as a weekly infusion of 640 mg following three loading doses, in combination
`with docetaxel and prednisone given as standard 3-week cycles. Patients in the active comparator arm received docetaxel and prednisone
`without custirsen. In both arms, patients were treated until disease progression, unacceptable toxicity, or completion of up to 10 cycles, unless
`additional cycles were deemed beneficial. Full efficacy and safety data from SYNERGY will be submitted for presentation at an upcoming scientific
`conference.
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`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. have entered a global
`collaboration and licensing agreement to develop and commercialize OncoGenex' lead drug candidate, custirsen. Custirsen utilizes second-
`generation antisense technology, licensed from Isis Pharmaceuticals (NASDAQ: ISIS), to effectively target and inhibit production of clusterin.
`OncoGenex and Isis partnered in the successful discovery of custirsen and in its initial development. 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.
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`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 benefits of 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 demonstrate the hypothesized or expected benefits, the risk of delays in our expected clinical trials 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.
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`http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=842949
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`4/17/2015
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`JANSSEN EXHIBIT 2077
`Wockhardt v. Janssen IPR2016-01582
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`

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`OncoGenex Announces Top-Line Survival Results of Phase 3 SYNERGY Trial Evaluatin...
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`Page 2 of 2
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`Copyright 2015 OncoGenex Pharmaceuticals, Inc.
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`http://ir.oncogenex.com/releasedetail.cfm?ReleaseID=842949
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`4/17/2015
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