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Shire Presents Positive Efficacy and Safety Data for velaglucerase alfa in Treatment of Naive Patients With Type 1 Gaucher Disease
Date:2/11/2010

an Genetic Therapies (HGT). "Our program is the largest and most comprehensive set of Phase III clinical trials conducted to date for Gaucher disease, and we look forward to presenting the results from the remaining trials at future scientific meetings."

Results from Five-Year Study

Ten of 11 adult patients who completed the Phase I/II study of velaglucerase alfa administered at 60 U/kg every other week, enrolled in a long-term extension study. After month-12, all patients were eligible to receive a step-wise dose reduction from 60 U/kg to 45 U/kg (13 weeks) and then to a 30 U/kg maintenance dose upon the achievement of specific therapeutic goals. All patients met therapeutic goals and their dose was subsequently titrated down to the 30U/kg dose. Seven of 10 patients received home infusions during the extension period. Eight patients (4 male, 4 female) have now received velaglucerase alfa treatment for 60 months.

After 5 years, velaglucerase alfa continued to be generally well tolerated and demonstrated substantial and prolonged increases in hemoglobin concentration and platelet count, and substantial and prolonged decreases in liver and spleen volumes in these patients with Type 1 Gaucher disease.

At 60 months, the mean increase in hemoglobin concentration from baseline was +2.4 g/dL (95% CI: 1.6, 3.2; 21.3% change) and the mean increase in platelet count from baseline was +85.1 x10(9)/L (95% CI: 59.8,110.4; 157% change). At 57 months, mean percent reduction in normalized liver volume from baseline was 39% (95% CI: -49.1%,-28.5%) and mean percent reduction in normalized spleen volume from baseline was 74% (95% CI: -89.3%,-58.6%).

Velaglucerase alfa was found to be generally well tolerated in these 10 patients with no drug-related serious adverse events reported. Treatment-emergent adverse events reported by at least 50% of patients included arthralgia, back pain, pyrexia, upper abdomi
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