Ceredase (Alglucerase) - Summary

CEREDASE SUMMARY

Ceredase^® (alglucerase injection) is a modified form of the enzyme,ß-glucocerebrosidase (ß-D-glucosyl-N-acylsphingosine glucohydrolase, EC 3.2.1.45). Alglucerase is a monomeric glycoprotein of 497 amino acids with carbohydrates making up approximately 6% of the molecule (M_r=59,300 as determined by SDS-PAGE). The unmodified enzyme (ß-glucocerebrosidase) also contains 497 amino acids and contains approximately 12% carbohydrate (M_r=67,000). The carbohydrates on the unmodified enzyme consist of N-linked carbohydrate chains of the complex and high mannose type. Glucocerebrosidase and alglucerase catalyze the hydrolysis of the glycolipid, glucocerebrosidase, within the lysosomes of the reticuloendothelial system.

Ceredase^® (alglucerase injection) is indicated for use as a long-term enzyme replacement therapy for children, adolescents and adult patients with a confirmed diagnosis of Type I Gaucher disease who exhibit signs and symptoms that are severe enough to result in one or more of the following conditions:

1. moderate-to-severe anemia;
2. thrombocytopenia with bleeding tendency;
3. bone disease;
4. significant hepatomegaly or splenomegaly.

CEREDASE NEWS HIGHLIGHTS

Published Studies Related to Ceredase (Alglucerase)

Mutation analysis of the acid beta-glucosidase gene in a patient with type 3 Gaucher disease and neutralizing antibody to alglucerase. [2001.11.01]

Anaphylactoid reaction to imiglucerase, but not to alglucerase, in a type I Gaucher patient. [1999.04]

Immunosurveillance of alglucerase enzyme therapy for Gaucher patients: induction of humoral tolerance in seroconverted patients after repeat administration. [1999.03.15]

[Uveitis masquerade syndrome in Gaucher disease. Causal treatment by alglucerase substitution therapy] [1998.12]

[Persistence of pulmonary lesions in a 6-year-old boy with type I Gaucher's disease treated by alglucerase since the age of 20 months] [1998.12]

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Clinical Trials Related to Ceredase (Alglucerase)

Safety and Efficacy of Cerezyme® Infusions Every 4 Weeks Versus Every 2 Weeks in Type 1 Gaucher Disease [Completed]

Study of GA-GCB Enzyme Replacement Therapy in Type 1 Gaucher Disease Patients Previously Treated With Imiglucerase [Recruiting]

A Multicenter Study of the Efficacy of Cerezyme in Testing Skeletal Disease in Patients With Type I Gaucher Disease. [Completed]

Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase [Not yet recruiting]

Phase I Single Dose-Escalation Safety Study of Human Glucocerebrosidase (prGCD) [Completed]

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