The European Commission has granted Orphan Drug Designation to Eleison Pharmaceuticals' ILC (Inhaled Lipid-complexed Cisplatin), for the treatment of osteosarcoma. Eleison Pharmaceuticals is a specialty pharmaceutical company developing life-saving therapeutics for rare cancers.
The designation follows the earlier positive opinion and recommendation of the European Medicines Agency (EMA) Committee of Orphan Medical Products. The Orphan Drug Designation provides Eleison access to protocol assistance and certain financial incentives from the EMA, as well as 10 years marketing exclusivity for ILC upon the receipt of marketing approval.
Dr Forrest Anthony, chief medical officer of Eleison Pharmaceuticals commented, “We are very pleased to receive Orphan Drug Designation by the European Commission, as ILC is potentially a breakthrough in the treatment of children and young adults with osteosarcoma, an often deadly cancer with little improvement in survival over the past 25 years. Our global phase II clinical for ILC remains ongoing with interim results expected in the middle of next year.”
Eleison has an exclusive worldwide license to ILC, a novel, sustained release formulation of cisplatin in a nanoscale lipid based complex administered via inhalation. ILC was designed to deliver high levels of sustained release cisplatin targeted to the lung, without systemic-related toxicities. ILC is currently being evaluated in a phase II clinical trial at leading medical centres in the United States.