TroVax recommended for OD status by COMP

UK-based gene therapy developer Oxford BioMedica says that the European Medicines Agency's (EMEA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion, recommending Orphan Drug designation for TroVax as a treatment for renal cancer.

Mike McDonald, Oxford BioMedica's chief medical officer, said that "the positive recommendation from the EMEA for Orphan Drug designation adds further momentum to the development of TroVax." Dr McDonald added that the decision underscores the need for effective treatments for renal cancer, where current therapeutic options are limited and the prognosis is poor.

Last month, the firm reported that it has initiated a Phase III trial of TroVax in the treatment of renal cancer (Marketletter November 13). The program, which is known as TRIST (TroVax Renal Immunotherapy Survival Trial), is designed to evaluate whether TroVax immunotherapy, when added to the standard regimen, prolongs the survival of patients with locally-advanced or metastatic clear cell carcinoma.