Based on discussions with the European Medicines Agency (EMEA) in the fourth quarter of 2008, the Company plans to initiate a separate clinical trial designed to evaluate the safety and efficacy of Amigal versus enzyme replacement therapy (ERT) in Fabry patients. Amicus and its partner Shire Human Genetic Therapies, Inc. (Shire HGT) plan additional discussions with the EMEA to finalize the design of this study.
In parallel with the Phase 3 regulatory discussions, 23 of the original 26 patients from the Phase 2 studies continue to be treated in a voluntary extension study to characterize the long-term safety and efficacy of Amigal and to evaluate additional doses and dose regimens. Amicus expects data from this extension study to be available in the first quarter of 2009.
Plicera(TM) (isofagomine tartrate) for the treatment of Gaucher Disease
During the fourth quarter, Amicus also focused on executing its ongoing Phase 2 clinical trial of Plicera in Gaucher disease. This 6-month study is designed to evaluate safety and to demonstrate trends of efficacy, as measured by the standard endpoints in Gaucher disease. Amicus previously reported that target enrollment is expected to be surpassed in the study and the Company expects the results to be available in the third quarter of 2009.
Amicus will continue to work closely with its partner, Shire HGT, to prepare for Phase 3 development of Plicera p
|SOURCE Amicus Therapeutics|
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