The designation is granted to drugs that are for serious conditions that affect not more than five in ten thousand persons in the European Community, and where there is limited alternative therapy for the disease.
Having gained orphan status for the Cloretazine, Vion can now look forward to ten years of market exclusivity for the drug in acute myeloid leukemia should it gain marketing approval. The company is also elegable to receive assistance from the European Medicines Agency (EMA) throughout the development and regulatory process, and access to European research funding.
Cloretazine is currently in a phase III trial in combination with cytarabine in relapsed acute myelogenous leukemia.
The drug is also being evaluated in a number of different cancer indications.