Ace Biosciences, Ace393, the World's First Commercial Vaccine
for Travellers' Diarrhoea Caused by Campylobacter Successfully
Completes Phase I Clinical Trials
Trial confirms good safety profile and strong immunogenicity
ODENSE, Denmark, March 28, 2007 -ACE BioSciences A/S, the infectious diseases company is pleased to announce the successful completion of Phase I clinical trials with its lead product, ACE393, the world's first commercial 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. The two stage, double blind, randomised, placebo-controlled trial confirmed that the vaccine was very well tolerated and that the strongest immune response was stimulated by the highest dose when administered in two doses either two or three weeks apart, with 100% of subjects responding. Adverse reactions were transient local site reaction and headaches in some subjects.
Dr Philippe Reboud, (Mediscis Phase I clinical unit) the study_s Principal Investigator commented "These are very satisfying results. The study clearly confirms the vaccine's safety and tolerability. Furthermore, at the 250µg dose, ACE393 stimulates a four fold increase in IgG antibody titre in all subjects, indicating strong immunogenicity (ability to stimulate an immune response). In the past it has proved too challenging to develop an effective vaccine against Campylobacter infection and Travellers' Diarrhoea has been difficult to prevent, leading to the incidence of serious long-term post infection complications such as Guillain Barre Syndrome and reactive arthritis in a few patients. However, thanks to the innovative approach taken by ACE BioSciences, this looks set to change."
Ms Ingelise Saunders, ACE BioSciences, C EO commented "I am delighted to report such positive results, which confirm the therapeutic and commercial potential of ACE393. This important outcome for ACE BioSciences validates our approach and preclinical work and keeps us on track to launch ACE393 in 2010. In September last year, we entered a collaborative development agreement with the US Naval Medical Research Center (NMRC) to progress ACE393 through Phase II clinical trials and we are about to initiate the first of these studies. These are exciting times for ACE BioSciences in a transformational year for the company."
72 healthy subjects participated in the trial which was undertaken at the Mediscis Phase I clinical unit in Poitiers, France. ACE BioSciences will continue to monitor those patients who received the vaccine at three monthly intervals to evaluate the longevity of the immune response. The full results of the study will be presented by Dr Michael Darsley, Chief Development Officer at ACE BioSciences at the Vaccines for Enteric Diseases Conference, held in Portugal on 25-27 April 2007.
TD is the most frequent health problem in travellers from industrialized countries visiting developing countries. Recent research undertaken by Beremans Ltd in the US and UK, indicates that an effective Campylobacter vaccine for Traveller's Diarrhoea might be purchased by over two million travellers per year and ACE BioSciences estimates that this annual global market would be worth _350 million. The company aims to claim a substantial share of the market by providing the first effective commercial Campylobacter vaccine that delivers good protection and low side effect risk.
Notes for Editors
About Travellers Diarrhoea
Campylobacter jejuni is a bacterium that is one of the main causes of travellers_ diarrhoea. In addition to the disruption it causes to business and holiday travellers, infection is a significant issue for the military and among the 140,000 US military perso nnel recently deployed in the Middle East, 76% reported at least one episode of diarrhoea and more than 50% reported multiple episodes.
Current travel patterns suggest that in 2020 there will be about 190 million susceptible individuals travelling from significant economies to regions at risk of TD. Under current conditions, 20% - 90% of these individuals would be expected to develop TD within two weeks of arrival. Similar numbers of individuals are likely to visit regions at intermediate risk of TD and about 8 _ 20% of these individuals would be expected to develop TD.
Antibiotics are frequently prescribed to treat infection and anti-diarrhoeal agents are used to treat the symptoms, but at present there is no commercially available vaccine to address Campylobacter jejuni.
ACE BioSciences is an emerging pharmaceutical company focused on developing novel protein-based vaccines and antibodies to address infectious diseases. It has unique expertise in the extraction and analysis of the cell surface proteins used by pathogens (eg bacteria, viruses and fungi) to interact with and infect human host cells. ACE BioSciences aims to develop a portfolio of products independently and in collaboration with other companies. In addition to ACE393, the company is working on a vaccine for Streptococcus pneumoniae, the bacterium responsible for Pneumococcal disease. The market for a Streptococcus product would be multibillion and ACE BioSciences aims to partner the project in the coming year. The company recently began work on a programme to address ETEC (enterotoxigeneic E coli), which is the primary cause of TD around the world.
In December 2005, ACE BioSciences announced a collaborative agreement with the Aeras Global TB Vaccine Foundation whereby ACE BioSciences will support the characterization of second-generation BCG-based tuberculosis (TB) vaccines under development by Aeras. In November 2005, ACE BioSciences and the Dutch bi otechnology company Crucell N.V. entered a research and licensing agreement to discover antibody therapies to combat serious hospital-acquired infections, including those caused by antibiotic-resistant bacteria. The company is also working with Nordic Vaccine A/S to develop patch and oral delivery technologies to enhance patient acceptability and delivery convenience.
Ingelise Saunders - ACE BioSciences + 45 6565 2121 or mob + 45 20 20 36 87
Nicki Brimicombe - NB PR for ACE BioSciences + 44 (0) 1883 732353