Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
AMICULUM Limited

AMICULUM® is an independent global healthcare communications, consulting and learning business with a global team of >220 healthcare communications professionals,...

Latest intelligence

GDPR and events. What does the pharma industry need to know?
...
Digital trends in B2B sales - how far behind is Pharma?
The modern approach to B2B sales is data-driven, and enabled by digital tools....
The rise of vertical integration in the US payer landscape
Is it a solution to addressing the challenges of the value-based marketplace?...

Infographics