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Osteosarcoma drug to enter Phase II in 2014
October 8, 2013
By: Gil Roth
President, Pharma & Biopharma Outsourcing Association
Eleison Pharmaceuticals has received Orphan Drug Designation for ILC (Inhaled Lipid-complexed Cisplatin) from the European Commission, for the treatment of osteosarcoma. The designation follows the earlier positive opinion and recommendation of the European Medicines Agency (EMA) Committee of Orphan Medical Products. 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, 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.”
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