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Date: Tuesday 07 Oct 2008
LONDON (ShareCast) - Shares in Oxford Biomedica surged ahead after positive talks with the US Food and Drug Administration (FDA) on further trials for its renal cancer drug TroVax.
The group slumped in July after a key safety monitoring board said final stage clinical trial of TroVax, which is being developed with French drugmaker Sanofi-Aventis, would not meet its defined goals.
Oxford said today that the FDA supported all aspects of its amended plan for the Phase III TRIST study of TroVax.
The FDA agreed to review additional data from the TRIST study, which Oxford BioMedica is currently collecting from clinical sites.
It has also offered to continue its dialogue with Oxford BioMedica and Sanofi-Aventis to determine the path forward for further trials.
“We are encouraged by the FDA’s feedback and guidance," said acting chief executive of Oxford Biomedica John Dawson.
"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," he added.