AFFINITY Trial to Continue as Planned Following Completion of Interim Futility Analysis
BOTHELL, Wash. and VANCOUVER, British Columbia, Jan. 16, 2015 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced that the AFFINITY trial is continuing as planned based upon completion of the interim futility analysis and the recommendation of the Independent Data Monitoring Committee (IDMC).
The Phase 3 AFFINITY trial is designed to evaluate a survival benefit for custirsen in combination with second-line cabazitaxel chemotherapy in 635 men with metastatic castrate-resistant prostate cancer (CRPC). AFFINITY is being conducted at 95 global clinical trial sites and final survival results are expected to be announced in late 2015 or early 2016.
"While the results remain blinded to OncoGenex, we are very pleased that the AFFINITY trial has passed this interim futility analysis and we remain confident in the potential value of custirsen in treating cancer, particularly in patients who have advancing disease despite previous treatments," said Scott Cormack, President and CEO of OncoGenex.
OncoGenex recently announced that it has executed an initial agreement with Teva Pharmaceuticals Industries, Ltd. to regain rights to custirsen, which is being evaluated in Phase 3 clinical development as a treatment for prostate and lung cancers.
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. 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 http://www.OncoGenex.com and at the company's Twitter account https://twitter.com/OncoGenex_IR.
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 serious adverse events (SAEs) associated with custirsen were febrile neutropenia, fever, pleural effusion and dyspnea, with each SAE event observed in approximately 2 to 4 percent of patients. In the Phase 3 SYNERGY trial, custirsen was administered to approximately 500 men with metastatic CRPC. Adverse events observed were similar to custirsen's known adverse event profile. The most common SAEs observed in 2 percent of patients treated with custirsen, beyond those observed in the control arm, included febrile neutropenia, pneumonia and fever. Although the SYNERGY trial did not meet its primary endpoint of significantly improved overall survival (OS) in combination with first-line docetaxel, exploratory analyses showed improved OS for some men who received custirsen and who had poor prognostic scores across several risk factors, including performance status ≤ 80.
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 design, as well as regarding the potential benefits and potential development of our product candidates and regarding the execution of a final agreement with Teva with respect to the termination of the collaboration agreement. 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 and the risk that a final agreement with Teva is not completed on the expected terms, if at all 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.