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Oxford Biomedica announces data safety monitoring board recommendation to continue TroVax (R) Phase III trial in renal cancer as planned |
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26 Jul 2007 |
Oxford BioMedica announced today that the independent Data Safety Monitoring Board (DSMB) for the Phase III TRIST study of TroVax in renal cancer has completed its first scheduled interim analysis
OXFORD, UK | July 25, 2007 | Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that the independent Data Safety Monitoring Board (DSMB) for the Phase III TRIST study of TroVax in renal cancer has completed its first scheduled interim analysis. The DSMB concluded that the trial should continue as planned without modifcation. The DSMB reviewed safety and anticancer immune responses from the first 50 patients enrolled. TroVax is Oxford BioMedica's novel cancer immunotherapy product, which is being developed in collaboration with sanofi-aventis.
The role of the DSMB is to evaluate data from the ongoing trial to determine whether there are safety issues or efficacy issues that would warrant modification of the protocol or early termination of the study. The DSMB is independent of Oxford BioMedica and sanofi-aventis and is comprised of leading clinicians and biostatisticians with relevant expertise in the treatment of renal cancer and the conduct of clinical trials.
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 randomised, placebo-controlled, two-arm study comparing TroVax in combination with standard of care to placebo with standard of care. The standard of care therapies are interleukin-2, interferon-alpha or Sutent® (sunitinib). The protocol stratifies treatment between the standard of care options to ensure that the allocation of TroVax and placebo is rigorously balanced.
The trial started in November 2006. To date, over 250 patients have been randomised of a target enrolment of approximately 700 patients. Approximately 100 sites of 150 identified centres in the USA, European Union and Eastern Europe are open for recruitment. The primary endpoint for the trial is survival improvement and secondary endpoints include progression-free survival, tumour response rates and quality of life scores. The trial is being conducted under a Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration (FDA). The SPA agreement ensures that the design, conduct, analysis and endpoints of the trial are all acceptable to the FDA. The trial is expected to complete in early 2009.
Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on the DSMB recommendation: "We are pleased that the immunology data from this first analysis of the Phase III TRIST study meet the pre-set criteria for continuation. The safety profile remains encouraging. Recruitment into TRIST has been rapid and we are on track to complete patient enrolment during Q1 2008."
SOURCE: Oxford BioMedica |
