Acambis concludes C. difficile vaccine formulation work on schedule and will commence proof-of-concept trial in 2008

20-Dec-2007

Acambis plc announced an update on its programme to develop the world's first vaccine against Clostridium difficile-associated disease (CDAD). C. difficile infection is the most common cause of hospital-acquired diarrhoea in the developed world, resulting in at least 360,000 cases of disease in the US alone, with estimated annual costs to the US and European healthcare systems totalling more than $5bn(1,2). During 2007, Acambis has been conducting formulation work to improve the stability profile of its C. difficile vaccine. It has completed this work on schedule and successfully identified a number of vaccine formulations that show improved stability profiles compared with material used in previous Phase 1 trials. It will select one of these formulations for the manufacture of clinical trial material to be conducted during 2008.

Acambis plans to initiate a proof-of-concept trial of its vaccine towards the end of 2008, which will provide data within 12-18 months of commencing the study. Acambis will provide further details on the trials and the overall development path for its C. difficile vaccine at an R&D day that it plans to hold early in the second quarter of 2008.

Dr Michael Watson, Acambis' Executive Vice President, Research & Development, said: "C. difficile-associated disease is a major public health problem and Acambis has the only vaccine in development. We have previously shown that this vaccine can achieve seroconversion rates of up to 100% and, with our formulation work now completed, we are focused on getting our vaccine to proof-of-concept as quickly as possible."

https://www.bionity.com/en/news/75972/acambis-concludes-c-difficile-vaccine-formulation-work-on-schedule-and-will-commence-proof-of-concept-trial-in-2008.html