Embargoed for 1 December 2008.....Odense, Denmark......ACE BioSciences, the company that develops vaccines to fight serious bacterial infections, has begun a landmark Phase IIb Proof of Concept study with ACE393, the world's first commercial Campylobacter Travellers' Diarrhoea (TD) vaccine. An interim analysis of the primary outcome will be complete by March 2009 at which point ACE BioSciences should be in a strong position to partner the project.

Ingelise Saunders, ACE BioSciences CEO, commented :

‘This is a milestone for ACE BioSciences and in the fight against Campylobacter infection. ACE BioSciences has worked with the US Naval Medical Research Center (NMRC) to establish the first Campylobacter challenge model that satisfies the US FDA's current safety requirements. The ability to evaluate our vaccine safely gives us clear competitive advantage and we are confident that ACE393 will be the first commercial vaccine to combat this common and debilitating bacterial disease. We estimate that the annual global commercial market for a Campylobacter vaccine is worth € 350 million and the military market represents a further significant opportunity.'

During the trial 40 subjects will receive the vaccine as two injections administered three weeks apart. A further twenty subjects will receive placebo injections. Three weeks after vaccination, subjects will be admitted to hospital and challenged with Campylobacter by drinking a suspension containing 100,000 bacteria. They will then be closely monitored for symptoms, which should develop within 48 hours. The extent of protection from moderate to severe diarrhoea will be evaluated as the end point for efficacy.

Any patient who experiences diarrhoea will receive antibiotic treatment and only be allowed home when the infection has successfully been addressed. Patients will be monitored for four weeks and then followed up at three and six months post-trial. The study is being managed by ACE BioSciences. It is being undertaken at the SNBL Clinical Research Centre, Baltimore, Maryland, US under the auspices of Dr Al-Ibrahim as Principal Investigator and with the support of the Johns Hopkins University and the University of Vermont, which are providing immunology and microbiology input.

The Campylobacter jejuni bacterium is one of the main causes of travellers' diarrhoea and it is responsible for significant disruption to many international travellers and military operations. Many strains of Campylobacter are associated with development of Guillain Barré Syndrome (GBS), a post-infectious polyneuropathy and infection also results in reactive arthritis in a few patients. As a result it has been difficult to develop a safe challenge model for new vaccine evaluation. Until now this has proved a barrier to vaccine development.  Antibiotics are frequently prescribed to treat infection and anti-diarrhoeal agents are used to treat symptoms. However, progressive development of antibiotic resistance has limited management options, further emphasising the need for primary prevention. 

ENDS 

For further information, please contact:

Ingelise Saunders

CEO, ACE BioSciences

Ph.: +45 20 20 36 87

E-mail: This e-mail address is being protected from spambots, you need JavaScript enabled to view it

About ACE BioSciences

ACE BioSciences is a product based company with a focus on vaccines to protect against infectious diseases caused by bacteria. The vaccines are developed in house through pre-clinical and clinical trials. The aim is to develop a portfolio of vaccines against travellers' diarrhoea and other serious infectious diseases. The company's lead products are ACE393, and ACE527 (Phase I), the first orally administered vaccine against ETEC which is being developed in collaboration with the international, nonprofit organization PATH (www.path.org). In the long term, the company aims to develop a combination vaccine to address Campylobacter and ETEC. In addition to its work on unmet vaccine needs, ACE BioSciences recognises the need to improve existing vaccines and is currently working to develop a new vaccine against Streptococcus pneumoniae.

ACE BioSciences was founded in 2001 from Odense University's Centre of Excellence in protein analysis. The technology platform is to extract and analyse the cell surface proteins used by bacteria, fungus and virus to infect human cells and thereby cause diseases. In December 2007, ACE BioSciences raised 11.9 million Euros to develop its diarrhoea vaccine portfolio. The company currently employs 20 staff. For more information: www.acebiosciences.com.