Positive results in Phase III study of VPRIV (Shire) for Gaucher-related bone disease

New data shows VPRIV (velaglucerase alfa for injection), from Shire, significantly improved selected markers of Gaucher-related bone disease in patients. A head-to-head Phase III study (HGT-GCB-039) of VPRIV and Cerezyme, and follow-on extension trial (HGT-GCB-044) of VPRIV, demonstrate a statistically significant improvement in lumbar spine (LS) bone mineral density in Gaucher patients starting at nine months of treatment with VPRIV, as measured by dual energy x-ray absorptiometry. Median LS Z-scores at baseline were -1.46 in patients treated with VPRIV, and -0.86 in patients treated with Cerezyme. Mean changes from baseline in LS Z-scores at nine months were 0.33 and 0.06, respectively. Following an additional 15 months of treatment, mean change in LS Z-scores improved to 0.64 for patients initially treated with VPRIV and improved to 0.54 for patients who switched to VPRIV from Cerezyme at nine months. Safety events observed in this study were similar to those seen historically. Data were presented by Professor Ari Zimran, Shaare Zedek Medical Center, Hebrew University and Hadassah Medical School, Jerusalem, Israel, at the European Working Group on Gaucher Disease meeting.