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Custirsen to enter second phase III trial

Teva and OncoGenex have announced the initiation of a global phase III trial evaluating custirsen as a therapy for castration-resistant prostate cancer

Teva and OncoGenex have announced the initiation of Synergy, a global phase III trial evaluating custirsen (also known as OGX-011/TV-1011) as first-line therapy for the treatment of castration-resistant prostate cancer (CRPC). The Synergy trial is the second of three phase III trials to be initiated under a global collaboration and licensing agreement between Teva and OncoGenex to develop and commercialise custirsen.

The Synergy trial is a randomised, controlled, global phase III trial to be conducted in approximately 125 cancer centres and with designated recruitment of 800 men with metastatic CRPC who have disease progression and require first-line docetaxel/prednisone chemotherapy.

Patients will be randomised to receive treatment with either docetaxel/prednisone plus custirsen or with docetaxel/prednisone alone.

The primary endpoint of the trial is to determine whether overall survival is longer in the custirsen treatment arm. The trial design is based on the phase II trial results demonstrating clinical benefits of custirsen treatment with a hazard ratio consistent with a 49 per cent reduction in the rate of death and a median overall survival of 23.8 months compared to 16.9 months.

The initiation of Saturn, the first phase III trial with custirsen, was announced by Teva and OncoGenex in June 2010. This global phase III trial will enrol patients with metastatic CRPC who have previously responded to first line docetaxel/prednisone treatment but subsequently have disease progression that involves pain despite opioid usage.

Custirsen has received Fast Track designation from the US Food and Drug Administration (FDA). Both phase III trials are being conducted through the Special Protocol Assessment (SPA) process.

In addition, the European Medicines Agency (EMA) indicated that the Committee for Medicinal Products for Human Use was in overall agreement with the custirsen development plan for commercialisation.

4th October 2010

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