Amicus, along with its partner Shire, has initiated discussions with the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) regarding its plans for Phase 3 clinical evaluation of Amigal. Amicus expects to complete these interactions and provide an update in the second half of 2008, and subject to the outcome of the discussions, the Company plans to initiate the Phase 3 clinical trial in the first half of 2009.
In parallel with the regulatory process, 23 of the original 26 patients continue to be treated with Amigal in the voluntary Phase 2 extension study to monitor long term safety and efficacy. In addition, the Company will evaluate modified doses and dose regimens in these 23 patients. Data from this extension study are expected to be available by Q1 2009, prior to finalization of the Phase 3 protocol.
Plicera(TM) (isofagomine tartrate) is an investigational, oral
therapeutic being developed for the treatment of Gaucher disease. At the
ACMG meeting in March, clinical investigators presented full data from a 4
week Phase 2 study in Gaucher patients who switched from enzyme replacement
therapy (ERT) with imiglucerase to the pharmacological chaperone Plicera.
Results showed that Plicera was generally safe and well tolerated at all
doses and increased target enzyme activity levels in a majority of
patients. In the trial, GCase activity, as measured in white blood cells,
was increased in 20 of the 26 pat
|SOURCE Amicus Therapeutics|
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