Patient enrolment in the phase III TRIST study of the novel cancer immunotherapy product TroVax® in renal cancer has been successfully completed, according to UK-based gene therapy firm Oxford BioMedica.
TroVax is being developed by Oxford BioMedica – set up in 1995 as a spin-out from Oxford University – in collaboration with Sanofi-Aventis.
More than 690 patients have been randomised to date, with total enrolment expected to exceed the 700-patient target.
More than 100 sites in the USA, EU and Eastern Europe have recruited patients.
Final results from the study are anticipated in 2009.
TRIST (TroVax Renal Immunotherapy Survival Trial) is a phase III trial in patients with locally advanced or metastatic clear-cell renal carcinoma.
The randomised, placebo-controlled, two-arm trial compares TroVax in combination with standard of care to placebo with standard of care, and is being conducted under an agreement with the FDA.
Dr Mike McDonald, Oxford BioMedica’s chief medical officer, said: “Completing recruitment so rapidly in such a large phase III trial is a significant achievement for us.
“We, together with our partner Sanofi-Aventis, believe that TroVax could provide an important treatment option for patients with renal cancer as well as potentially other common types of cancer.
“We are delighted that, within the next few months, sanofi-aventis will broaden the development programme for TroVax with the start of the first Phase III trial of TroVax in colorectal cancer.”
TroVax is designed to stimulate an anti-cancer immune response and has potential application in most solid tumour types.
It targets the tumour antigen 5T4, which is broadly distributed throughout a wide range of solid tumours. The presence of 5T4 is correlated with poor prognosis.
The product consists of a modified vaccinia Ankara virus vector, which delivers the gene for 5T4 and stimulates a patient’s body to produce an anti-5T4 immune response.
This immune response destroys tumour cells carrying the 5T4.