H.I.G. Capital News
OncoGenex Announces Completion of a Special Protocol Assessment (SPA) Amendment with the FDA Increasing Patient Eligibility for the Custirsen Phase III Prostate Cancer SATURN Clinical Trial
Trial Criteria Updated to Reflect Changing Chemotherapy Standard of Care in the Treatment of Metastatic Castrate-Resistant Prostate Cancer and Maintains SPA Granted by the FDA
BOTHELL, WA & VANCOUVER - September 19, 2011 - OncoGenex announced that the company has successfully completed an amendment to the approved SPA with the U.S. Food and Drug Administration (FDA) to expand the inclusion criteria for the Prostate Cancer SATURN Clinical Trial - a Phase III study testing whether their experimental drug custirsen, also known as OGX-011/TV-1011, can improve quality of life by reducing cancer pain for more than 12 weeks in men with metastatic castrate-resistant prostate cancer (mCRPC). As part of the approved amendment to the protocol and the SPA, patients may now receive either docetaxel re-treatment or cabazitaxel as second-line taxane chemotherapy. The study design remains the same; all patients must have stable pain at study entry and will be randomized to receive custirsen or placebo in conjunction with taxane chemotherapy.
"Until recently, docetaxel was the only standard of care for chemotherapy treatment of mCRPC with a demonstrated survival benefit," said Dr. Tomasz Beer, the study's principal investigator in the United States. "With the recent approval of cabazitaxel for mCRPC treatment after docetaxel, men have a new option that extends survival. In an effort to improve the palliative benefits of this new treatment, we are evaluating custirsen with cabazitaxel for pain palliation. Pain palliation in patients treated with cabazitaxel was reported at 9.2% and pain is one of the most common and devastating consequences of very advanced prostate cancer."
Custirsen is an experimental drug that is designed to block the production of a protein that is associated with treatment resistance in many cancers. In Phase II trials, custirsen combined with docetaxel as either first-line or second-line chemotherapy showed a 6.9 month improvement in overall survival over docetaxel alone, and 51% of patients experienced durable pain palliation for a duration of 12 weeks or longer, respectively.
Prostate cancer often spreads to the bone, making it especially painful. While newly approved therapies are helping to improve overall survival, most have not been shown to significantly relieve pain quickly or for extended periods of time.
"Now that men with mCRPC are living longer thanks to new therapies and better management of the disease, optimal therapy should not only extend life but also improve quality of life," said Dr. Cindy Jacobs, OncoGenex' Chief Medical Officer. "SATURN is a unique Phase III trial with a primary focus on long-term pain palliation - an important unmet need for men with this disease, and their families."
The Prostate Cancer SATURN Clinical Trial is designed to enroll approximately 300 men with mCRPC who have completed first-line docetaxel chemotherapy, are experiencing disease progression, and are on narcotic medications to manage their prostate cancer-related pain. The trial is being conducted throughout North America and in select European countries. In addition to allowing patients who previously progressed while receiving first-line docetaxel chemotherapy to be enrolled into the study and receive cabazitaxel, other modifications were made to inclusion and exclusion criteria that should significantly expand eligibility.
The SYNERGY trial will evaluate an overall survival benefit for custirsen in combination with first-line docetaxel treatment. We aim to demonstrate through these trials that custirsen can both extend and improve the lives of prostate cancer patients.
For more information about the trial, visit www.ProstatePainStudy.com or if you think you may be eligible, contact a SATURN trial specialist at 1-877-888-3762.
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.OncoGenexandTeva Pharmaceutical Industries Ltd.(NASDAQ:TEVA) have entered a global collaboration and license agreement to develop and commercialize OncoGenex' lead drug candidate, custirsen. Custirsen is currently in Phase III clinical development as a treatment in men with metastatic castrate-resistant prostate cancer. The companies plan to begin Phase III development of custirsen in first-line treatment of advanced, unresectable non-small cell lung cancer. OGX-427 is in Phase II clinical development; CSP-9222 and OGX-225 are 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 dates and patient enrollment targets, and the potential benefits 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 of delays in our expected clinical trials and the uncertainties regarding patient enrollment rates, the risk that our product candidates do not obtain the requisite regulatory approvals to commercialize, the risk that new developments in the rapidly evolving prostate cancer therapy landscape require additional changes in our clinical trial design or limit the potential benefits of our product and the other factors described in our risk factors set forth in our filings with theSecurities and Exchange Commissionfrom time to time, including the Company's Quarterly Report on Form 10-Q for second quarter endedJune 30, 2011. 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.