Biosearch Italia SpA says that its North American licensee for the novelantibiotic ramoplanin, IntraBiotics Pharmaceuticals, has reported a delay in the timetable for completion of Phase III clinical studies.
IntraBiotics informed the Italian company that patient enrollment in the Phase III study is not sufficient to complete the trial by end-2001, the previously anticipated timeframe for reporting data. The study, which began enrollment in June 2000, is designed to demonstrate whether treatment with ramoplanin reduces the incidence of bloodstream infections due to vancomycin-resistant enterococci in cancer patients known to carry VRE in their intestines.
VRE commonly affect cancer patients undergoing chemotherapy, and Biosearch notes that, with a limited number of treatments available, patients suffer from infections, require an extended hospital stay and have high mortality rates.
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