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OncoGenex Announces Initiation of Randomized Phase 2 "PACIFIC" Study of OGX-427 in combination with Zytiga® in Men with Metastatic Castrate-Resistant Prostate Cancer
Bothell, WA and Vancouver, BC – December 19, 2012 – OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today the initiation of PACIFIC, an investigator-sponsored, randomized Phase 2 study evaluating OGX-427 in men with metastatic castrate-resistant prostate cancer (CRPC) who are experiencing a rising PSA while receiving Zytiga (abiraterone acetate). The aim of the study is to determine if adding OGX-427 to Zytiga treatment can reverse or delay treatment resistance.
Approximately 80 men who are being treated with Zytiga and have evidence of a rising PSA, but no evidence of symptomatic or radiographic progression, will be randomized to either continue treatment with Zytiga and prednisone alone, or have OGX-427 added to the Zytiga and prednisone treatment. Patients will be stratified based on whether they have received prior chemotherapy and will continue on study until symptomatic, radiographic or other documented disease progression occurs. The primary objective will be to compare the two treatment groups for delaying further disease progression while on Zytiga by assessing the progression-free survival (PFS) rate at 60 days after adding OGX-427. Secondary objectives include comparing the treatment arms for PSA responses, objective responses, time to progression, circulating tumor cells (CTCs) and other biomarkers.
"The rationale for PACIFIC is based on the idea that resistance to treatment is caused by cancer cells using adaptive pathways to escape and proliferate," said Scott Cormack, President and CEO of OncoGenex Pharmaceuticals. "OGX-427 and Zytiga are potentially synergistic because they disrupt androgen receptor signaling in different ways. We believe that by adding OGX-427 to Zytiga in patients who are experiencing a rising PSA we may be able to reverse treatment resistance and extend the benefits of Zytiga."
PACIFIC will be conducted at approximately 15 sites in the US and Canada and is being managed by the Hoosier Oncology Group. Dr. Kim Chi from the British Columbia Cancer Agency, Dr. Christopher Sweeney from the Dana Farber Cancer Institute and Dr. Noah Hahn from the Indiana University Simon Cancer Center, will serve as the primary investigators on the study. Dr Noah Hahn is also the Chief Scientific Officer for the Hoosier Oncology Group.
About OGX-427 and The "ORCA" Program
OGX-427 is designed to inhibit the production of Heat Shock Protein 27 (Hsp27), a cell-survival protein found at elevated levels in many human cancers including prostate, bladder, breast and non-small cell lung cancer. Overexpression of Hsp27 is thought to be an important factor leading to the development of treatment resistance and is associated with negative clinical outcomes in patients with various tumor types. The "ORCA" (On-going studies evaluating treatment Resistance in CAncer) program encompasses clinical studies aiming to demonstrate that inhibition of Hsp27 can lead to improved prognosis and treatment outcomes for cancer patients. For more information on OGX-427 and ORCA, please visit www.oncogenex.com.
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 license 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. OGX-427 is in Phase 2 clinical development and OGX-225 is currently in pre-clinical development.
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 our anticipated product development activities, such as expected clinical trial completion and statements regarding the potential benefits and potential development 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. Such forward-looking statements are subject to risks and uncertainties, 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, 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, the risk that our cash resources are insufficient to fund our planned activities for the time period expected 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.
Zytiga is a registered trademark of the Johnson & Johnson Corporation