CORRECTED - UPDATE 1-FDA approves Oxford, Sanofi cancer trial changes
(Corrects to colorectal from renal in paragraph four; also fixes typographical error in Reuters Instrument Code for Oxford Biomedica)
LONDON, Oct 7 (Reuters) - Oxford Biomedica Plc (OXB.L) said U.S. regulators had approved a series of amendments to a study for its lead drug TroVax in renal cancer, being developed alongside French drugmaker Sanofi-Aventis (SASY.PA).
The new agreement with the Food and Drug Administration may mean Oxford can continue development of the drug for a specific population subset, having said in July the drug had missed its key goal in its leading renal cancer trial TRIST.
At that time a key safety monitoring board advised the company to stop vaccinations of TroVax in renal cancer because it said there were too many patient deaths, sending Oxford shares sharply lower.
Oxford also said in its latest statement on Tuesday Sanofi-Aventis would carry on with the development of the drug in colorectal cancer, as long as a review of interim data was positive and the FDA was on board.
Oxford's acting Chief Executive John Dawson said: "The agreed amendments to the TRIST study should enable us to identify the optimal setting and regimen for TroVax in renal cancer and we remain optimistic that TroVax may show benefit in a subset of patients.
"We continue to work with our partner, Sanofi-Aventis, to explore the data arising from the TRIST study and to map the optimal development path for TroVax. (Reporting by Ben Deighton; Editing by David Holmes)
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