SCICLONE'S ZADAXIN GRANTED ORPHAN-DRUG DESIGNATION

A A

SciClone Pharmaceuticals has announced that thymalfasin, the chemical composition of Zadaxin, has been granted orphan-drug designation for the treatment of Stage IIb through stage IV malignant melanoma by the FDA.

Zadaxin currently is being investigated in combination with dacarbazine (DTIC) chemotherapy with and without low-dose interferon alpha in a large, multicenter Phase II Stage IV malignant melanoma trial in Europe. In December 2005, SciClone and Sigma-Tau reported encouraging interim data on overall tumor response showing a distinct Zadaxin dose-dependent response in combination with DTIC chemotherapy with and without low-dose interferon alpha.