Oxford BioMedica (LSE: OXB), the leading gene therapy company, announced today that it has received a Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration (FDA) for a Phase III trial of TroVax in renal cell carcinoma. The written agreement from the FDA specifies the design, conduct, analysis and endpoints of the trial, which, if successful, will support an efficacy claim in a regulatory submission for product registration. The SPA was received at the end of the FDA’s first review period following Oxford BioMedica’s application in March 2006. Oxford BioMedica plans to start the trial in the second half of 2006.
