Genzyme says phase 2 trial shows tolevamer as effective as vancomycin in treatment of diarrhea

By Lisa Kerner

Charlotte, N.C., Aug. 15 - Genzyme Corp. said tolevamer in a phase 2 trial demonstrated similar outcomes as vancomycin in the treatment of Clostridium difficile-associated diarrhea (CDAD), including time of resolution of diarrhea, and a strong trend toward a reduced recurrence rate of CDAD.

The results of the randomized, double-blind study of about 300 patients were published in the Aug. 15 issue of Clinical Infectious Diseases.

CDAD, a sometimes fatal form of infectious diarrhea caused by the bacterium C. difficile, can be the result of antibiotic treatment that alters the normal bacteria in the colon.

Tolevamer binds and removes toxins from the body released by C. difficile that damage the large intestine.

In two ongoing phase 3 studies, tolevamer is being compared to two commonly prescribed antibiotic therapies for CDAD, vancomycin and metronidazole.

Genzyme expects to complete its tolevamer trials in 2007 with commercial approval of the product anticipated in 2008.

A Cambridge, Mass., biotechnology company, Genzyme develops polymer-based therapies for serious diseases.

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