24.02.2015 14:12:39
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Cytori Gets Positive European Opinion On Orphan Drug Status - Quick Facts
(RTTNews) - Cytori Therapeutics, Inc. (CYTX) said the European Medicines Agency's Committee for Orphan Medicinal Products or COMP issued a positive opinion toward Cytori's application for an orphan drug designation for the new Scleroderma therapeutic ECCS-50, which contains adipose tissue-derived stromal vascular fraction cells derived from Cytori's proprietary Celution System.
Recently, the company Cytori received FDA approval to study the same therapeutic, ECCS-50, in an 80 patient Phase 3 pivotal trial for Scleroderma associated hand dysfunction. Currently, this trial is planned to begin enrolling this year in around 12 U.S. sites.
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