July 11, 2008
Oxford Announces DSMB’s Recommendation for Phase III Renal Cancer Study
Oxford BioMedica has announced that the independent data safety monitoring board for the Phase III Trist study of TroVax in renal cancer has recommended that the trial should continue but that further vaccinations be discontinued.
Following its fourth interim review of the Trist study, the data safety monitoring board (DSMB) advised that TroVax administered according to the protocol will not meet the predefined primary efficacy endpoint, but there is important scientific merit and more to be learned by additional follow up of all patients.Hence, the DSMB's recommendation is to continue the study but discontinue further vaccinations. Oxford BioMedica has implemented the DSMB's recommendation. In addition, the Company intends to amend the statistical plan of the study to determine whether patient outcome is dependent on the number of TroVax doses administered.
Oxford BioMedica and, its partner, Sanofi-Aventis, will evaluate the available data and the implications on the development plan for TroVax, including the planned Phase III trials in colorectal cancer. The companies will discuss the proposed Trist protocol amendments with the regulatory authorities.
The Trist study is a randomized and placebo-controlled Phase III trial, designed to evaluate TroVax in combination with standard of care in locally advanced or metastatic clear cell renal carcinoma. The original trial protocol, which was the subject of a special protocol assessment by the FDA, allowed for patients to receive up to 13 immunizations over 73 weeks.
Mike McDonald, CEO of Oxford BioMedica, said: "This news is clearly disappointing. However, there is good reason to continue the study and potentially a late survival benefit for TroVax may still be demonstrated. The proposed trial amendment will assess whether the maximum benefit-to-risk ratio is dependent on an optimal number of doses. We remain optimistic that TroVax may show benefit in this population after these protocol amendments."