R]Galen announced today that the European Commission has designated liposomal daunorubicin as an orphan medicinal product for the treatment of acute myeloid leukaemia (AML).
Speaking about the European Commission orphan medicinal product designation for liposomal daunorubicin, Mark Scrutton, President of Galen, commented: "We are delighted about the designation of liposomal daunorubicin as an orphan medicinal product for the treatment of acute myeloid leukaemia, a life-threatening disease.
The Phase I study enrolled 18 patients with biopsy-proven AIDS-related KS, 17 of whom had suffered recurrent disease following prior therapy with drugs such as liposomal daunorubicin
, paclitaxel and liposomal doxorubicin, and 14 of whom were receiving highly active anti-retroviral therapy.
Phase I Trial of Liposomal Daunorubicin
(DaunoXome) Administered with High-Dose Cytarabine (Ara-C) to Patients with Relapsed Acute Leukemia," by Larry Cripe, of Indiana University Medical Center, Indianapolis, et al.
We have concluded that Vestar's liposomal daunorubicin
is safe and effective in producing objective and subjective responses in Kaposi's sarcoma, and that the drug may be the treatment of choice in this disease," stated Dr.