Abstract
Genzyme General is developing recombinant human alpha-glucosidase, produced in mammalian cell culture, as a potential treatment for Pompe disease. By July 2004, enrollment was completed in two clinical trials and an observational study in adults. Genzyme was planning to file for regulatory approval in Europe during 2004, followed by filings in the US and Japan in mid-2005.
MeSH terms
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Animals
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Clinical Trials as Topic
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Glycogen Storage Disease Type II / drug therapy*
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Glycogen Storage Disease Type II / enzymology
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Humans
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Recombinant Proteins / chemistry
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Recombinant Proteins / pharmacokinetics
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Recombinant Proteins / therapeutic use
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Structure-Activity Relationship
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Treatment Outcome
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alpha-Glucosidases / chemistry
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alpha-Glucosidases / deficiency
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alpha-Glucosidases / pharmacokinetics
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alpha-Glucosidases / therapeutic use*
Substances
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Recombinant Proteins
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alpha-Glucosidases