ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), announced today that The Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA) adopted a positive opinion for darinaparsin (Zinapar™ or ZIO-101) designation as an orphan medicinal product for the treatment of peripheral T-cell lymphoma (PTCL). A positive opinion by the COMP immediately precedes official designation of darinaparsin as an orphan drug by the European Commission (EC). Intravenous darinaparsin has demonstrated evidence of activity in lymphoma, in particular PTCL. ZIOPHARM expects to initiate a registration-directed study of darinaparsin in patients with PTCL by the end of 2011.
"Orphan designation recognizes the acute need for new therapies for unmet medical needs, in this case addressing PTCL, an aggressive form of lymphoma for which there remains such a need," said Jonathan Lewis, M.D., Ph.D., Chief Executive Officer and Chief Medical Officer of ZIOPHARM.
Orphan Drug Designation by the EC provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU). In addition to a 10-year period of marketing exclusivity in the EU after product approval, Orphan Drug Designation provides companies with scientific advice and regulatory assistance from the EMA during the product development phase, direct access to centralized marketing authorization, as well as reductions in certain fees associated with the application and approval process.
In September, ZIOPHARM announced that darinaparsin was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of PTCL.
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