OXFORD REPORTS TROVAX DATA

Oxford BioMedica has announced preliminary data from the Phase II trial of TroVax in renal cell carcinoma (RCC). The data show that TroVax is safe and well-tolerated in this patient group and that the product induces a strong antitumor immune response against the 5T4 tumor antigen.

The Phase II trial is an open-label study of TroVax in combination with interleukin-2 (IL-2) therapy, which is an FDA-approved treatment for RCC. Patients receive five immunizations of TroVax over 12 weeks and up to four cycles of high-dose IL-2. Patients who show an antitumor immune response to TroVax will be offered an additional three vaccinations. The primary endpoints of the trial are safety and immunogenicity. Secondary efficacy endpoints include tumor responses, time to disease progression and overall survival.

The trial is intended to recruit up to 25 patients, in order to gather information on the safety of TroVax in this setting and also the ability of TroVax to elicit immune responses to the tumor antigen 5T4. To date, seven patients have been recruited. There have been no serious adverse events related to TroVax, which is consistent with the safety profile of the product across all trials, and TroVax treatment has been well-tolerated.