H.I.G. Capital News
A Phase III Clinical Trial Testing Long-Term Pain Management in Men With Metastatic Castrate-Resistant Prostate Cancer Is Open and Enrolling
BOTHELL, WA & VANCOUVER, BC - September 21, 2011 - Strides have been made in the last few years in improving treatment and extending survival for men with metastatic castrate-resistant prostate cancer (mCRPC), meaning prostate cancer that no longer responds to hormone therapy and has spread to other parts of the body.
However, as the disease continues to progress, commonly spreading to the bone, it becomes more difficult to treat and can become very painful -- leading many with the disease to lose the ability to perform even simple daily tasks such as standing up and walking around. Those living with mCRPC-associated pain often need to take narcotics like morphine, which can cause intolerable side effects.
What is the Prostate Cancer SATURN [www.ProstatePainStudy.com] Clinical Trial?
SATURN is a Phase III clinical trial testing whether a drug called custirsen (OGX-011/TV-1011) can reduce pain caused by mCRPC for 12 weeks or longer. Results of earlier clinical studies showed that custirsen in combination with chemotherapy reduced prostate cancer-related pain and improved overall survival. The goal of the Prostate Cancer SATURN Clinical Trial is to confirm previous pain reduction study findings in a larger group of men with mCRPC*.
"As new therapies allow us to extend survival for men with late-stage prostate cancer, we must also focus on improving quality of life for those with the disease," said Dr. Tomasz Beer, Deputy Director, OHSU Knight Cancer Institute; Professor of Medicine, Division of Hematology & Medical Oncology. "In addition to potentially improving survival outcomes, custirsen may also help relieve pain, and the SATURN trial is unique in specifically addressing pain in this population."
For more information about the Prostate Cancer SATURN Clinical Trial, go online to www.prostatepainstudy.com or call 1-877-888-3762 to speak to a clinical trial specialist.
*Custirsen is also being investigated as a potential combination therapy with first-line docetaxel chemotherapy for mCRPC in another Phase III clinical trial with overall survival as the primary endpoint.
Custirsen is an experimental drug that is designed to block the production of clusterin, a protein that, when over-produced, can be associated with treatment resistance in many types of cancer. Pre-clinical and other data suggest that clusterin promotes tumor cell survival. Moreover, increased clusterin production has been linked to faster rates of cancer progression, treatment resistance and shorter survival duration.
Custirsen has been administered to 294 patients with various types of cancer in Phase I and Phase II clinical trials. Five Phase II clinical trials have been conducted to evaluate the ability of custirsen to enhance the effects of therapy in prostate, non-small cell lung, and breast cancer. In Phase II trials in patients with metastatic castrate-resistant prostate cancer custirsen combined with either first-line or second-line docetaxel 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.
In clinical trials with custirsen, some patients experienced one or more adverse events -- the majority of which were attributable to either the disease itself or other treatments in the protocol. Most adverse events were mild and those commonly associated with custirsen consisted of flu-like symptoms. The most common serious adverse events associated with custirsen were neutropenia, vomiting, dehydration, pyrexia, pleural effusion and dyspnea, which occurred in greater than 2% of patients.
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. (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.
More information about OncoGenex 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 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 the Securities and Exchange Commission from time to time, including the Company's Quarterly Report on Form 10-Q for second quarter ended June 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.
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