Fabio Pammolli, Massimo Riccaboni, Laura Magazzini, Mark Supekar


Fabio Pammolli, Massimo Riccaboni, Laura Magazzini, Mark Supekar

Tabella 4.14. Fase di sviluppo clinico delle molecole designate orfane

Product Designated Orphan Indication Sponsor Designation date Phase

8-cyclopentlyl-1,3-dipropylxanthine cystic fibrosis SciClone Pharmaceuticals Italy S.r.l 30/01/2001 fase II

Ramoplanin invasive infections due to Vancomycin


Resistant Enterococci (VRE) in colonised

patients deemed at risk of infection

Vicuron Pharmaceuticals Italy srl 15/02/2001 fase III

Repertaxin L-lysine salt delayed graft function in organ transplant Dompé s.p.a. 21/02/2001 fase I

Thymalfasin hepatocellular carcinoma SciClone Pharmaceuticals Italy S.r.l 30/07/2002 fase II

Caffeine citrate primary apnoea of premature newborns Chiesi Farmaceutici S.P.A. 17/02/2003 registrazione

Abagovomab ovarian cancer Menarini Ricerche S.p.A. 09/07/2003 fase II/III



Herpes simplex 1 virus-thymidine

kinase and truncated low affinity

nerve growth factor receptor

transfected donor lymphocytes

chronic idiopathic myelofibrosis Abiogen Pharma S.p.A. 20/10/2003 clinica

adjunctive treatment in hematopoietic

cell transplantation

MolMed SpA 20/10/2003 fase III

Defibrotide hepatic veno-occlusive disease Gentium S.p.A. 29/07/2004 fase III

Biotinylated anti-tenascin

monoclonal antibody for use with 90-


glioma Sigma Tau Industrie Farmaceutiche

Riunite S.p.A

20/10/2004 fase I

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