Clostridium difficile
Clostridium difficile is now recognised as the major cause of infectious diarrhœa in hospitalised patients. The organism causes a broad spectrum of symptoms, collectively known as C. difficile associated disease (CDAD), ranging from mild to severe diarrhœa, and rarely to pseudomembranous colitis, toxic megacolon, intestinal perforation and even death, from secondary sepsis. Most strains of the bacteria produce two toxins, known as A and B, which are thought to be responsible for the above symptoms.
Rates of CDAD are increasing in the US and Europe. One study in the US suggests that there was a near doubling of C. difficile infections in the period 1995-2002, and there are now an estimated 500,000 cases of CDAD in the US each year. In the UK the rate rose by around 98% from 2001 to 2004, and in 2006 the HPA received 55,213 reports of CDAD from England, Wales and Northern Ireland. C. difficile-related mortality rates are also increasing: from 5.7 to 23.7 per million of the US population from 1999 to 2004 and from 10 to 38.5 per million of the UK population between 1999 and 2005.
The treatment and prevention of C. difficile infections would benefit enormously from the availability of a selective antibiotic which could remove C. difficile but leave the normal gut flora unharmed, thus ensuring there is no niche in the gut for C. difficile to fill. Phico’s technology is ideally placed to address these markets and a SASPjectTM system targeted to C. difficile is currently being developed for oral use as a therapeutic agent against CDAD. It is anticipated that this C. difficile SASPjectTM will be further developed for co-administration with broad spectrum antibiotics in target populations as a prophylactic to prevent CDAD infection.
Manufacture and pre-clinical trials are planned for 2009.