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February 15, 2013
10:36 EDTFOLDAmicus Theraputics presents additional data from Fabry monotherapy study
Amicus Therapeutics announced additional 6-month results from the first ongoing Phase 3 global registration study of investigational oral migalastat HCl monotherapy in males and females with Fabry disease who had genetic mutations identified as amenable to migalastat HCl in a cell-based assay. Study 011 consists of a 6-month, double-blind period when subjects received migalastat HCl 150 mg or placebo, a 6-month open label-follow up period when all patients received migalastat HCl, and an ongoing 12-month open-label extension. Initial top-line Stage 1 results previously reported in December, 2012 for the primary endpoint in Stage 1 did not meet statistical significance. The pre-specified primary and secondary analyses of the primary endpoint numerically favored migalastat HCl over placebo. In the primary responder analysis, 13/32 in the migalastat HCl group versus 9/32 in the placebo group demonstrated a 50% or greater reduction in kidney interstitial capillary GL-3 from baseline to month 6. Taken alone the secondary analysis of the absolute percent change in kidney interstitial capillary GL-3 from baseline to month 6 showed a median reduction of 41% in the migalastat HCl group versus a median reduction of 6% in the placebo group. Stage 1 results were highlighted in an oral platform presentation at the Lysosomal Disease Network WORLD Symposium.
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February 24, 2015
08:33 EDTFOLDArgos Therapeutics hires Joan Winterbottom as Chief Human Resources Officer
Argos Therapeutics (ARGS) announced that Joan Winterbottom will join the company as chief human resources officer. Winterbottom most recently served as senior vice president of human resources at Amicus Therapeutics (FOLD).
February 23, 2015
07:22 EDTFOLDSunTrust to hold a conference
2015 Biotechnology and Pharmaceutical 1:1 Orphan Drug Day is being held in New York on February 23.

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