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news.OncoGenex Pharmaceuticals has initiated a randomised, controlled, international Phase 3 registration trial of Custirsen Sodium (OGX-011/TV-1011), its lead product candidate being developed for the treatment of castrate-resistant prostate cancer (CRPC).
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OncoGenex Pharma said that this trial is the first of three Phase 3 trials to be initiated under a global collaboration and license agreement between OncoGenex and Teva Pharmaceutical Industries to develop and commercialise OGX-011/ TV-1011.
This Phase 3 trial will be conducted in approximately 50 cancer centers and is expected to enroll approximately 300 men with metastatic CRPC who have previously responded to first-line docetaxel therapy, but subsequently have disease progression that involves prostate cancer-related pain despite opioid usage.
In the trial, the patients will be randomised to receive retreatment with docetaxel/prednisone plus OGX-011/ TV-1011 or docetaxel/prednisone plus placebo in a blinded manner.
The primary endpoint of the Saturn trial will be to determine whether durable pain palliation for 12 weeks or more is observed in a greater proportion of patients treated with docetaxel/prednisone plus OGX-011/ TV-1011 compared to docetaxel/prednisone plus placebo.
The Saturn trial design is based on the Phase 2 data in patients with metastatic CRPC who were treated with OGX-011/ TV-1011 in combination with docetaxel/prednisone retreatment as second-line chemotherapy.
Additionally, a separate Phase 2 trial evaluating OGX-011/ TV-1011 in combination with first-line chemotherapy showed that patients with advanced metastatic prostate cancer who were treated with OGX-011/ TV-1011 plus docetaxel had a median overall survival of 23.8 months compared to 16.9 months for patients treated with docetaxel alone — a 6.9 month observed survival advantage for the OGX-011/ TV-1011 arm.
OGX-011/ TV-1011 has received fast track designation from the FDA and this Saturn trial is being conducted through the Special Protocol Assessment (SPA) process.
In 2009, Teva Pharmaceutical Industries and OncoGenex Pharmaceuticals have entered into a global license and collaboration agreement to develop and commercialise OGX-011/TV-1011.
Tomasz Beer, proincipal incestigator of the trial, said: “In the Phase 2 trial, almost half of patients who had pain or were on opioids and were retreated with docetaxel/prednisone with the addition of OGX-011/ TV-1011 had durable pain palliation for 12 weeks or more. This is better than expected based on pain responses seen after initial treatment with docetaxel/prednisone.”