Oxford BioMedica plc, a gene-based biopharmaceutical company, and Cardiff University announced a Phase II trial to assess the safety and immunological activity of TroVax(R), a therapeutic vaccine for patients with inoperable metastatic colorectal cancer (CRC). The study will be funded by Cardiff University, with some funding awarded by Cancer Research Wales, and Oxford BioMedica will provide TroVax(R). The trial is supported by the Experimental Cancer Medicine Centre (ECMC), Cardiff.  

Colorectal cancer is the second most common cause of cancer mortality in the UK with an estimated 16,000 deaths per year (source: Cancer Research UK, 2010). TroVax(R) is a therapeutic vaccine that stimulates the immune system to destroy cancerous cells expressing the 5T4 tumour antigen which is present on most solid tumors. It is well-documented that low doses of cyclophosphamide can augment immune responses by decreasing the numbers of a class of blood cell called a "regulatory T cell". By combining TroVax(R) with cyclophosphamide, this study will determine whether the combination approach results in stronger immune responses against 5T4 compared to patients treated with TroVax(R) alone.

The randomized, open-label Phase II study, entitled "TaCTiCC" (TroVax(R) and Cyclophosphamide Treatment in Colorectal Cancer), builds on four previous Phase I/II trials conducted by Oxford BioMedica where TroVax(R) was given to patients with CRC, in addition to research into CRC undertaken by Dr Andrew Godkin and Dr Awen Gallimore at Cardiff University, Wales. Led by Dr Andrew Godkin, the study will enroll up to 54 patients with inoperable metastatic CRC. 

The study will evaluate whether TroVax(R), administered alone or in combination with cyclophosphamide, is effective in the treatment of CRC. The 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.  

 Commenting on the collaboration, Stuart Naylor, Chief Scientific Officer at Oxford BioMedica, said, "We believe TroVax(R) holds great promise in the treatment of colorectal cancer and very much look forward to working with our 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." 

 Dr Andrew Godkin, Principal Investigator at Cardiff University, commented, "We are very excited in Cardiff to be starting this study. It is a truly translational study in as much as preliminary data have been generated from a series of experiments which started over 10 years ago. There has been a tremendous amount of support from various parties to drive this forward, the logistic hurdles are crossed and we are now ready to go."