ACE Biosciences and US Naval Medical research Center Collaborate to Progress World’s First Campylobacter Vaccine for Travellers’ Diarrhoea Through Phase II Trials

ACE BioSciences A/S, the infectious diseases company and the US Naval Medical Research Center (NMRC) have signed a collaborative development agreement whereby the two groups will progress ACE BioSciences’ lead product, ACE393, through Phase II clinical trials. ACE393 is scheduled to be the world’s first vaccine for Travellers’ Diarrhoea (TD) caused by Campylobacter infection.

ACE393 is an injectable vaccine designed to combat the bacterium Campylobacter jejuni, one of the greatest causes of bacterial diarrhoeal infections in the developed world. Infection is a significant issue for the military. Among the 140,000 US military personnel recently deployed in the Middle East, 76% reported at least one episode of diarrhoea and more than 50% reported multiple episodes.

The Enteric Diseases Department within the NMRC has very broad experience of working with Camplyobacter, Shigella and ETEC (enterotoxigenic E coli), all of which cause travellers’ diarrhoea. The team has extensive expertise, capabilities and knowledge regarding the conduct of clinical research and has successfully undertaken a number of clinical trials with therapies and vaccines to address enteric disorders. However, a vaccine for Campylobacter has remained elusive.

ACE BioSciences recently began Phase I clinical trials to evaluate the safety, tolerability and immunogenicity of ACE393. The collaborative team is developing a safe, effective Campylobacter jejuni challenge model in which volunteers will be fed a suspension of

C jejuni to induce a well defined level of diarrhoeal disease. Once this is complete the collaborative Phase II study is scheduled to begin in the latter half of 2007. The study will evaluate the safety, immunogenicity and preliminary efficacy of ACE393 and take the form of an experimental vaccination challenge study, whereby volunteers will be vaccinated with ACE393 and then monitored following Campylobacter infection, according to the previously developed challenge model, to evaluate the level of protection afforded by the vaccine.

Ms Ingelise Saunders, ACE BioSciences’ CEO commented “The NMRC has over 20 years experience in the field of enteric disease and I am delighted that a group with such in-depth knowledge and international status has chosen to collaborate with ACE BioSciences. Their commitment and their involvement should facilitate the effective execution of its Phase II development. If all goes to plan we should be ready to launch ACE393 in 2010.

According to CAPT Stephen Savarino, Director of the Enteric Diseases Department, Naval Medical Research Center, the U.S. Navy has had a longstanding commitment to develop effective vaccines against Campylobacter diarrhea and dysentery, due to the importance of this disease in deployed military forces. "The collaboration being established with ACE BioSciences positions us to work closely on the development of a new, safe volunteer challenge model of Campylobacter diarrhea, and then to use this tool to establish the efficacy of ACE393, ACE Biosciences’ lead Campylobacter vaccine candidate," reported CAPT Savarino. He pointed out that, if successful, the availability of a safe, effective Campylobacter vaccine would positively influence military readiness and travelers' health, not to mention the potential for improvement of global public health.