Third Phase 3 Trial of Custirsen to Receive FDA Fast Track Designation
BOTHELL, Wash. and VANCOUVER, British Columbia, April 23, 2014 /CNW/ - OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of custirsen when administered in combination with cabazitaxel/prednisone for the treatment of men with metastatic castrate-resistant prostate cancer (CRPC) following prior treatment with a docetaxel-containing regimen.
Fast track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.
The international, randomized, open-label Phase 3 AFFINITY trial is designed to evaluate if custirsen, when combined with second-line chemotherapy cabazitaxel and prednisone, has the potential to improve survival outcomes for prostate cancer patients compared to second-line chemotherapy alone. AFFINITY will enroll approximately 630 men and is expected to complete enrollment in the second half of 2014.
Custirsen has also received Fast Track designation from the FDA for treatment of patients with metastatic non-small cell lung cancer as part of the Phase 3 ENSPIRIT trial and for men with metastatic CRPC as part of the Phase 3 SYNERGY trial. Enrollment in the ENSPIRIT trial is ongoing and top-line survival results from SYNERGY are expected by mid-2014.
For more information on the AFFINITY trial, including centers currently enrolling patients, please visit www.prostatecancerstudy.com.
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 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 licensing 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. 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.
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 regulatory timelines and the potential market opportunity for 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 receive regulatory approval as or when expected, the risk that our product candidates will not successfully be commercialized 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.
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