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Shire Presents Positive New Data at the 60th Annual American Society of Human Genetics (ASHG) for Patients with Type 1 Gaucher Disease
Date:11/4/2010

rval of –0.60 g/dL in both populations, greater than the pre-defined non-inferiority margin of –1.0 g/dL. These results indicate that the primary endpoint was met. Both the VPRIV and imiglucerase groups showed substantial improvements in the secondary endpoints, including platelet counts, spleen volume, liver volume, and plasma biomarkers with no statistically significant difference demonstrated between the treatment groups. The majority of adverse events were mild or moderate in severity, including one serious adverse event (SAE) seen with VPRIV which was an allergic skin reaction that resolved without sequalae.

Shire also reported important findings that suggested substantial antigenic differences when antibody response to treatment with VPRIV and imiglucerase were compared. No patient treated with VPRIV developed anti-drug antibodies while 4 patients in the imiglucerase group developed antibodies to imiglucerase. Of these four imiglucerase treated patients, 1 patient had antibodies that inhibited enzyme activity in vitro and enzyme uptake in a cell-based assay. 3 patients had antibodies that did not inhibit enzyme activity or uptake.

Data from the Phase III clinical trial extension were also presented at ASHG. In the six month extension study patients from study 034 with type 1 Gaucher disease previously treated with imiglucerase, successfully transitioned to VPRIV and maintained hematological parameters at therapeutic levels through 18 months of continuous treatment. VPRIV was generally well tolerated, and appeared to show a favourable immunogenicity profile.

"For physicians, drug safety is a major consideration; the reported lack of antibodies to infused velaglucerase alfa in these studies, both in naive and switch patients, is re-assuring to patients and their physicians alike," said Gregory M. Pastores MD, Associate Professor of Neurology and Pediatrics at the NYU School of Medicine in New York.

Shire's VPRIV clinical t
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