OXFORD, England—The U.S. Food and Drug Administration sent Oxford BioMedica a Special Protocol Assessment May 12, which will pave the way for the gene-therapy company to begin phase 3 studies of its renal cell carcinoma drug TroVax.
The phase 3 trial will evaluate whether TroVax immunotherapy, added to first line standard of care therapy, extends the survival of patients with locally advanced or metastatic clear cell renal adenocarcinoma.
The protocol assessment established the design, conduct, analysis and endpoints of the trial. Approximately 700 patients from the United States and Europe will be involved in the study. Oxford BioMedica plans to start the trial in the second half of 2006.
The primary endpoint will be survival improvement and secondary endpoints will include progression free survival, tumor response rates and quality of life scores. The study will also look into the safety and potential efficacy of the drug combinations at various time points during the trial.
In addition, Oxford is seeking ‘orphan drug’ status for TroVax in the United States and Europe for renal cell carcinoma.