DSMB Recommends Continuation of Oxford BioMedica's Phase III Cancer Study
Posted on: Thursday, 21 February 2008, 12:00 CST
Oxford BioMedica has reported that the independent Data Safety Monitoring Board or DSMB for the Phase III TRIST study of TroVax in renal cancer has completed its third planned interim analysis and recommended that the study continue without modification.
The continuation of the trial following this interim analysis triggers a milestone payment to Oxford BioMedica of E10 million. TroVax is Oxford BioMedica's novel cancer immunotherapy product, which is being developed in collaboration with sanofi-aventis.
TRIST (TroVax Renal Immunotherapy Survival Trial) is a Phase III trial of TroVax in patients with locally advanced or metastatic clear cell renal carcinoma. The trial is a randomized, placebo-controlled, two-arm study comparing TroVax in combination with standard of care to placebo with standard of care. To date, over 600 patients have been randomized and more than 100 sites in the US, EU and Eastern Europe are recruiting patients.
Alan Kingsman, CEO of Oxford BioMedica, said: "The trial is on track to complete patient enrollment before the end of the first quarter of 2008 and we anticipate final results in 2009. In addition to further progress of the TRIST study in renal cancer, future events will include Sanofi-aventis commencing its planned Phase III trial of TroVax in patients with metastatic colorectal cancer."
Source: Datamonitor
Related Articles
- Oxford Announces DSMB's Recommendation for Phase III Renal Cancer Study
- Sanofi-Aventis Reports Positive Results From Phase II Renal Cancer Trials
- Antisoma Starts Phase I Clinical Trial of AS1409 in Renal Cancer and Melanoma
- Exelixis Initiates Phase 1/2 Trial of XL184 in Patients With Non-Small Cell Lung Cancer
- Identify Key Prescribing Factors That Influence Prescription Patterns for Systemic Therapy in Renal Cancer
- Oxford Biomedica and Sanofi-Aventis Report New TroVax(R) Phase II Trial Results in Renal Cancer
- Sciele Begins to Enroll Patients in a Pivotal Phase III Clinical Trial for the Combination of Pravastatin and Fenofibrate
- Exelixis Initiates Phase II Trial of XL880 in Patients With Gastric Cancer
- Oxford Biomedica Plc Announces Oxford BioMedica Presents Encouraging Final Phase II Results With Trovax(R) in Colorectal Cancer at the International Colorectal Cancer Congress
 |
 |
User Comments (0)
RSS Feeds