Primary Registration Phase 3 Study for Custirsen in Advanced Prostate Cancer Now Fully Enrolled
BOTHELL, Wash. and VANCOUVER, British Columbia, Nov. 6, 2012 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today the completion of patient enrollment in the primary registration Phase 3 study, known as SYNERGY, evaluating custirsen in patients with advanced prostate cancer.
The SYNERGY study is designed to evaluate a survival benefit for custirsen, when added to first-line chemotherapy, in men with metastatic castrate-resistant prostate cancer (mCRPC). The SYNERGY study is the first of two, ongoing, pivotal Phase 3 studies evaluating a potential survival benefit for custirsen treatment in prostate cancer.
Over 1000 men have been enrolled to the SYNERGY study, at 142 sites primarily in North America and Europe. The survival primary endpoint data are event-driven and results are expected by the end of 2013.
"Completing enrollment of SYNERGY is an exciting and important milestone for the custirsen development program and for our company," said Scott Cormack, President and CEO of OncoGenex Pharmaceuticals. "We are one step closer to our goal of truly understanding the clinical benefit of custirsen in a large, randomized Phase 3 study, and to bringing forward a new treatment that could potentially extend the lives of men with prostate cancer."
The SYNERGY trial was initiated based on results of the OncoGenex Phase 2 trial in patients with metastatic CRPC receiving custirsen in combination with first-line docetaxel chemotherapy. These patients experienced a 6.9 month improvement in overall survival in comparison with those patients who received docetaxel alone.
Custirsen has received Fast Track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with docetaxel. The FDA has also agreed on the design of the SYNERGY trial through the special protocol assessment (SPA) process.
Custirsen is the only compound currently in development designed to inhibit the production of clusterin, a protein commonly over-produced in cancer cells, and one cause of treatment resistance. As part of Phase 1 and Phase 2 clinical trials, custirsen was administered to 294 patients with various types of cancer. Some of the patients experienced a variety of adverse events, the majority of which were associated with other treatments in the protocol and the disease. The majority of adverse events were mild and 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.
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. More information is available at www.OncoGenex.com.
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 final trial results will not demonstrate the same or any potential benefit as observed in preliminary trial results, the risk that subsequent studies may not confirm earlier trial results, 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.
SOURCE OncoGenex Pharmaceuticals, Inc.