Treatment begins in Ph III Trovax study
UK gene therapy company Oxford BioMedica says that the first patient has been treated in TRIST, a pivotal multicenter Phase III trial of its novel cancer immunotherapy, TroVax, in patients with advanced or metastatic renal cell carcinoma. Approximately 700 patients will be recruited into this randomized, placebo-controlled, two-arm study, across 120 centers in the USA, European Union and eastern Europe.
TRIST's primary endpoint is survival improvement and secondary endpoints include progression-free survival, tumor response rates and quality of life scores. The duration of the trial will be determined by the number of deaths. Oxford BioMedica expects it to reach a conclusion in 2008-09, which would support the company's objective of registering Trovax in 2009.
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