The UK’s National Cancer Research Network has adopted a Phase III clinical trial for gene therapy specialist Oxford BioMedica’s novel cancer immunotherapy TroVax. National Health Service centres in the UK will now join other sites participating in the TRIST (TroVax Renal Immunotherapy Survival Trial) study across the European Union and Eastern Europe.

The TRIST trial will evaluate whether adding TroVax to first-line standard therapy, such as interleukin-2, interferon-alpha or Sutent (sunitnib, Pfizer), prolongs the survival of patients with locally advanced or metastatic clear-cell renal carcinoma. The first patient was treated last November and Oxford Biomedica is aiming at a total cohort of 700, with US sites to start recruiting soon. The trial should be completed in 2008/09, on target for product registration in 2009. TroVax is Oxford BioMedica’s lead cancer immunotherapy compound and is under development for renal, colorectal, prostate and breast cancer in more than 10 clinical studies.

Improvement in patient care for NHS

The NCRN, which provides an infrastructure for clinical trials in the NHS, decided to adopt the TRIST study after its Renal Cancer Clinical Study Group evaluated TroVax and the trial design, concluding that the product offered “potential improvement in patient care for the NHS”, Oxford BioMedica noted. There were no financial obligations or loss of commercial rights tied to the network’s involvement, it added. Professor Barry Hancock, chairman of the National Cancer Research Institute Clinical Studies Group, said there was a “real need for novel, safe and effective” treatments for renal cell carcinoma.

This is the second time in less than a month that the NCRN has adopted a clinical trial for a new cancer therapy under development by a biopharmaceutical company based in the UK. The network recently agreed to take on a Phase IIb study of Onyvax-P, a cell vaccine designed by Onyvax Ltd to stimulate an immune response against prostate cancer. Announcing the addition of UK centres to its development programme on 11 December, the company pointed out that the Onyvax-P trial was the first industry-sponsored protocol to be adopted by the NCRN since the launch of the UK government’s ‘Best Research for Best Health’ strategy for the NHS in January 2006.

The government’s objectives for research and development in the NHS over the next five years included making the UK “a leading country for conducting clinical research in partnership with and for industry." Accordingly, one of the aims of the umbrella UK Clinical Research Network, set up in February 2005 to spearhead the development of a nationwide infrastructure for clinical research in the health service, was to “strengthen research collaboration with industry and ensure that the NHS can meet the health research needs of industry," the strategy report stated.

Overcoming barriers to research

In response, the UKCRN has established a dedicated industry team that works closely with the healthcare industries, the Department of Health and NHS Trusts to identify and resolve barriers to the delivery of clinical research in the UK. Initiatives in this vein include providing prompt and reliable assessments of study feasibility through well-established links with network study sites; and facilitation of study site activation through the use of standardised agreements and costing processes. The UKCRN has also developed a streamlined adoption process for industry-contract studies, informed by discussions with companies through the UKCRC Industry Road Map Group and setting a 14-day target for decisions on adoption and feasability of new research proposals.

Established in 2001 and now part of the UKCRN, the National Cancer Research Network served as the model for other NHS research networks in the fields of stroke, diabetes, neurodegenerative disease, mental health and paediatric medicines. It has the benefit of relative experience, 40 local research networks across the UK and a dramatically expanded pool of patients. Cancer patient accrual rates for clinical trials in the UK have jumped from 3% in 2001 to a world-leading 11% today. By Peter Mansell