E. coli
TD Vaccines A/S announced Jan. 25 the early results of a preliminary vaccine to combat a leading cause of bacterial diarrhea that afflicts millions of international travelers as well as children in the developing world.
The small Phase I trial studied ACE527, a live, three-strain, oral ETEC (Enterotoxigenic E. Coli) vaccine.
In the Phase I trial, involving 36 adult volunteers (12 placebo; 12 on low dose and 12 on high dose vaccine), ACE527 was very well tolerated, demonstrated a strong safety profile and showed promising initial immunological data, the company said.
The project will now proceed to a Phase II challenge study with clinical proof of concept anticipated by the year end.??
ACE527 is a live, whole-cell ETEC vaccine that comprises three attenuated ETEC strains and induces both colonization factor and toxin specific immune responses.
The Phase I study showed a mucosal immune response to colonization factors on all three strains and confirmed that the vaccine generates a strong mucosal and systemic anti-toxin response as well.
The trial was conducted at the Center for Immunization Research at Johns Hopkins University in Baltimore, where the Phase II trial will also take place.??
“ACE527 is an attractive commercial opportunity since there is no ETEC vaccine currently available to protect travelers and market potential is valued at €900 million. The project is fully funded by PATH, an international nonprofit global health organization, to the conclusion of proof of concept and I am delighted by their ongoing commitment to this work,” said Ingelise Saunders, CEO of TD Vaccines.
??TD Vaccines is a Danish biotechnology company established in November 2009.
Enterotoxigenic E. coli strains are one of the most common causes of bacterial diarrhea. A great many people travelling from developed to developing countries for business or holidays succumb to infection, which results in reduced productivity, ruined vacations and considerable personal discomfort.
ETEC is responsible for an estimated 840 million gastrointestinal infections and approximately 380,000 deaths worldwide each year. Moreover, in the developing world diarrhea is the second leading cause of death in children under the age of 5 and ETEC is responsible for a significant portion of these fatalities.
The Phase II trial aims to recruit 72 subjects (36 will receive vaccine and 36 placebo) of whom 56 will be challenged with a virulent strain of ETEC (28 subjects each having received vaccine or placebo). The trial is scheduled to start in the second quarter of 2010.
