Genzyme Begins Study of Nonantibiotic Therapy for CDAD
Genzyme has announced that physicians have treated the first patients in a Phase III clinical study to test the safety and efficacy of tolevamer, an investigational polymer therapy for patients with Clostridium difficile associated diarrhea (CDAD), a form of infectious diarrhea caused by the bacterium C. difficile.
Tolevamer is being developed as a new, nonabsorbed therapy that could be the first nonantibiotic treatment approved for CDAD. Tolevamer is designed to bind and remove from the body toxins released by C. difficile that damage the intestine. A nonantibiotic approach has the potential to treat CDAD and reduce the number of disease recurrences, resulting in improved quality of life for the patient and significant savings to the healthcare system.
The Phase III study will be conducted at more than 250 clinical sites in North America, Europe and Australia, and involve more than 1,000 patients. Enrollment is expected to take approximately 18 months to complete.