The FDA orphan drug designation provides potential incentives such as funding for clinical studies, study design assistance, waiver of FDA user fees, tax credits and, importantly, up to seven years of market exclusivity upon marketing approval.
William Peters, CEO and Chairman of Adherex, said: “Our experience to date combining ADH-1 and melphalan for the treatment of in-transit melanoma has been very encouraging. To continue with the rapid development of this combination, two additional centers, Lehigh Valley and H Lee Moffitt, have joined our Phase IIb trial which is ongoing at Duke and the MD Anderson.”