A Phase 3 Clinical Trial of Custirsen in Combination with Docetaxel as Second-Line Treatment in Patients with Non-Small Cell Lung Cancer to be Initiated Later this Year
BOTHELL, Wash. and VANCOUVER, British Columbia, July 10, 2012 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today an update on the clinical development program for custirsen and details on plans to initiate a Phase 3 clinical trial in non-small cell lung cancer (NSCLC).The trial, planned to begin enrollment later this year, will evaluate the potential survival benefit of combining custirsen with docetaxel, a standard second-line chemotherapy treatment used in patients who have progressed after initial, or first-line, treatment has failed.
The Phase 3 trial will be an international, randomized, open-label study that will enroll approximately 1,100 patients with advanced or metastatic NSCLC who have been previously treated with a first-line platinum-based chemotherapy. Patients will be randomized to receive custirsen plus docetaxel or docetaxel alone. The primary objective of the study will be overall survival with additional secondary and exploratory analyses of other efficacy outcomes and biomarker relationships. Two formal interim analyses are planned for stopping the trial early based on inadequate evidence of clinical benefit or futility. No interim analyses for claiming efficacy are planned.
Custirsen is designed to block production of clusterin, a cell survival protein that is commonly overexpressed in several cancer types and in response to anticancer treatments. Phase 2 data from a single-arm study evaluating custirsen in combination with a gemcitabine/platinum-based regimen in first-line NSCLC were published earlier this year. The data demonstrated a median overall survival of 14.1 months, decreased serum clusterin levels in 95% of patients evaluated, with lower serum clusterin levels during study treatment correlating to longer survival outcomes, and a toxicity profile not felt to be appreciably different than those reported for previously published similar combinations.
"We are pleased that we and Teva have identified a clear path forward to evaluate custirsen in patients who are suffering from this terrible disease," said Scott Cormack, President and CEO of OncoGenex Pharmaceuticals. "In previous studies in prostate and other cancers, custirsen has been shown to work synergistically with docetaxel, a globally accepted standard of care in advanced lung cancer. We are excited about the initiation of this trial and its potential to improve outcomes for patients."
In addition to the planned Phase 3 study in NSCLC, custirsen, in combination with chemotherapy, is currently being evaluated in Phase 3 trials for patients with castrate-resistant prostate cancer (CRPC). Custirsen has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for treatment of patients with CRPC receiving first-line docetaxel chemotherapy.
Lung cancer is the second most common cancer in both men and women and the leading cause of cancer-related death. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined. This year, in the United States alone, approximately 226,160 new cases of lung cancer will be diagnosed and an estimated 160,340 patients will die of the disease.
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 our 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 are 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.
About OncoGenex Pharmaceuticals
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new cancer 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. 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 initiation and 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. 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.