OncoGenex Pharmaceuticals has completed enrolling advanced prostate cancer patients in its Phase III study of custirsen.
Custirsen is designed to restrain the production of clusterin, a protein usually over-produced in cancer cells that can contribute to treatment resistance.
OncoGenex president and CEO Scott Cormack said the completion of enrolment is an important milestone for the custirsen development programme.
"We are one step closer to our goal of truly understanding the clinical benefit of custirsen in a large, randomised Phase III study, and to bringing forward a new treatment that could potentially extend the lives of men with prostate cancer," Cormack added.
The study, named Synergy, will assess the survival benefit for custirsen, when combined with first-line chemotherapy, in male patients with metastatic castrate-resistant prostate cancer (mCRPC). The survival primary endpoint data are event-driven.
The study has enrolled over 1,000 men at 142 sites mainly in North America and Europe, and is anticipated to deliver results by the end of 2013.
OncoGenex considered the results of the company’s Phase II trial conducted in patients with metastatic CRPC receiving custirsen in combination with first-line docetaxel chemotherapy to commence the SYNERGY study.
A 6.9 month improvement in the overall survival was reported in patients who received combination chemotherapy in comparison with those patients who received docetaxel alone.
Image: Micrograph showing prostatic acinar adenocarcinoma (the most common form of prostate cancer). Photo: Courtesy of Nephron.