Oxford BioMedica, a gene-based biopharmaceutical company, has announced the initiation of a Phase II collaborative study for TroVax in inoperable metastatic colorectal cancer (CRC) patients.
The randomised, open-label Phase II study will assess anti-5T4 immune responses following treatment, in addition to secondary measures of clinical benefit, including progression-free survival, objective response rate and overall survival.
The study, which is supported by the Experimental Cancer Medicine Centre (ECMC), Cardiff, will be funded by Cardiff University, with some funding awarded by Cancer Research Wales, while Oxford BioMedica will provide TroVax.
Oxford BioMedica chief scientific officer Stuart Naylor said the company believes that TroVax holds promise in the treatment of colorectal cancer and looks forward to working with colleagues at Cardiff University.
"This important study builds on pioneering work undertaken by Dr Godkin and his team and we are pleased to be able to support the transition into Phase II clinical development," Naylor added.
The study, entitled TroVax and Cyclophosphamide Treatment in Colorectal Cancer (TaCTiCC), will enrol up to 54 patients with inoperable metastatic CRC.
The trial, by combining TroVax with cyclophosphamide, will determine if the combination approach results in stronger immune responses against 5T4 compared to patients treated with TroVax alone.
Cardiff University principal investigator Andrew Godkin said, "It is a truly translational study in as much as preliminary data have been generated from a series of experiments that started over ten years ago."