Therapy for C Difficile Diarrhea

A phase III clinical study is testing the safety and efficacy of tolevamer, an investigational polymer therapy for patients with Clostridium difficile-associated diarrhea (CDAD).

C difficile is a spore-forming bacterium that is found widely in the environment and is known to survive for months in hospitals and long-term care facilities. Patients are at risk of developing CDAD when they are treated with antibiotics that alter the normal, protective bacteria that reside in the colon. Virually all antibiotics have been implicated in causing CDAD, and the number of infections has been increasing in recent years.

Tolevamer is a new, nonabsorbed therapy that could be the first non-antibiotic treatment approved for CDAD. It is designed to bind and remove from the body the toxins released by C difficile that damage the intestines. Tolevamer is being developed by Genzyme Corp. (Cambridge, MA, USA). The phase III study will be conducted at more than 250 sites in North America, Europe, and Australia and involve more than 1,000 patients. The study will also evaluate tolevamer against metronidazole, the most commonly prescribed antibiotic treatment for CDAD.

"C difficile represents a significant risk to many hospitals and long-term care patients, especially among the elderly,” noted Georges Gemayel, executive vice-president of Genzyme Corp. "We are encouraged by data that indicate that tolevamer may be particularly valuable in reducing recurrence and repeat hospitalization for these patients.”