Oxford Biomedica to test Trovax in phase 3 renal cancer trial

By Elaine Rigoli

Tampa, Fla., May 12 - Oxford BioMedica has received a Special Protocol Assessment agreement from the Food and Drug Administration for a phase 3 trial of TroVax in renal cell carcinoma, expected to start in the second half of 2006.

The written agreement from the FDA specifies the design, conduct, analysis and endpoints of the trial, which could support an efficacy claim in a regulatory submission for product registration.

The phase 3 trial, referred to as Trist (TroVax renal immunotherapy survival trial), will evaluate whether TroVax immunotherapy, added to first line standard-of-care therapy, prolongs the survival of patients with locally advanced or metastatic clear cell renal adenocarcinoma.

The trial will be a randomized, placebo-controlled, two-arm study of TroVax in combination with standard of care versus a placebo with standard of care.

The Special Protocol Assessment was received at the end of the FDA's first review period following Oxford BioMedica's application in March 2006.

Oxford BioMedica, based in Oxford, United Kingdom, is a biopharmaceutical company specializing in the development of gene-based therapeutics with a focus on oncology and neurotherapy.

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