Cytori Granted Orphan Drug Status For Cellular Therapeutic In EU - Quick Facts

(RTTNews) - Cytori Therapeutics Inc. (CYTX) announced that the European Commission, acting on the positive recommendation from the European Medicines Agency Committee for Orphan Medicinal Products, has designated Cytori's ECCS-50 cellular therapeutic as an orphan medicinal product for the treatment of scleroderma.

The designation marks the first autologous adipose derived cell therapy for scleroderma granted orphan status in the European Union or EU.

Cytori said it is currently working with leading scleroderma centers in France led by the Assistance Publique des Hôpitaux de Marseille to begin a 40 patient EU pivotal trial called SCLERADEC-II. The trial is a follow-up controlled trial to the first SCLERADEC trial published last August (Granel et al. Annals of the Rheumatic Diseases, 2014). If successful, this trial would potentially lead to EMA approval of Cytori's lead therapeutic for this indication in the EU, as an ATMP or Advanced Therapy Medicinal Product.

Cytori recently received FDA approval for a phase 3 clinical trial with our ECCS-50 therapeutic in 80 patients with scleroderma associated hand dysfunction. This US clinical trial is currently planned to begin enrolling this year and has recently been granted FDA approval to expand the number of centers from 12 to 20 sites.