Sanofi-aventis reports positive results from Phase II renal cancer trials

Oxford BioMedica has completed four Phase II trials of TroVax in metastatic renal cancer in a total of 88 patients to evaluate the safety, immunogenicity and efficacy of TroVax in combination with standard therapy or as a single agent.

The three trials enrolled 61 patients in centers in the USA and UK. Although each of these studies had differing patient cohorts in terms of prior treatment, concomitant therapy and histological type of tumor, all studies indicated that TroVax was well tolerated and generated consistent and robust immune responses to the tumor antigen 5T4 (55 of 60 evaluable patients, 92%).
The most frequent TroVax-related side effect was low-grade transient irritation at the injection site. Furthermore, all studies showed encouraging levels of clinical benefit relative to historical controls.

A Phase III Trist study is ongoing in patients with locally advanced or metastatic clear cell renal carcinoma and is expected to complete in the first half of 2009. Phase III trials in colorectal cancer are expected to start in 2008.

TroVax is Oxford BioMedica’s therapeutic cancer vaccine, which is being developed in metastatic renal cancer and other solid cancers in collaboration with Sanofi-aventis.

Mike McDonald, chief medical officer of Oxford BioMedica, said: “With our partner, Sanofi-aventis, we continue to be encouraged by the Phase II results of TroVax. These updated analyses of three trials in metastatic renal cancer further support the mechanistic rationale that the immune response induced by TroVax has potential for clinical use in this setting.”