Taliglucerase alfa: Preliminary Phase III data

Preliminary data from the first 15 patients in an open-label, crossover, international Phase III trial showed that switching from Cerezyme imiglucerase to an equivalent dose of IV taliglucerase alfa every 2 weeks for 9 months led to no increased safety concerns while maintaining efficacy. Specifically, hemoglobin and platelet counts, as well as mean spleen and liver volumes, remained stable over 9 months with no drug-related serious adverse events or hypersensitivity reactions reported. The trial was originally designed to enroll 15 patients, but was expanded to include 30 patients as a result of the shortage of enzyme replacement therapy for Gaucher's patients. Genzyme Corp. (NASDAQ:GENZ, Cambridge, Mass.), which markets Cerezyme, has faced supply shortages of the Gaucher's disease drug since last year due to viral contamination and other problems at the company's Allston, Mass., facility (see BioCentury, Aug. 30). ...