A positive opinion by the COMP immediately precedes official designation of darinaparsin as an orphan drug by the European Commission (EC).
Ziopharm expects to commence a registration-directed study of Darinaparsin in patients with PTCL by the end of 2011.
Ziopharm CEO and chief medical officer Jonathan Lewis said orphan designation recognizes the acute need for new therapies for unmet medical needs, in this case addressing PTCL.