Primary Liver Cancer - Celsion’s ThermoDox Treatment Awarded Orphan Drug Designation

A leading oncology drug development company, Celsion Corporation (NASDAQ:CLSN) recently announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued a positive opinion on the application for Orphan Drug Designation for the drug ThermoDox. This drug would be used in the treatment of hepatocellular carcinoma, more commonly known as primary liver cancer. ThermoDox has already achieved the Orphan Drug designation by the U.S. Food and Drug Administration (FDA).

A positive opinion by the COMP immediately precedes official designation of ThermoDox as an orphan drug by the EMA. ThermoDox is currently being evaluated under a Special Protocol Assessment with the FDA in a 600 patient pivotal Phase III trial (the HEAT study) in patients with non-resectable primary liver cancer at 76 clinical sites in 11 different countries.

Orphan drug designation by the EMA means certain incentives and aid for the product developer. These include scientific advice, regulatory assistance, access to marketing EMA marketing authorization, and special financial inducements. The designation also allows for a myriad of fee waivers concerning the development phase; pre-authorization inspection fees, marketing application fees, and general annual fees.

“We are very pleased to receive a positive opinion from the Committee for Orphan Medicinal Products, which immediately precedes final Orphan Drug designation from the EMA, for ThermoDox,” stated Mr. Michael H. Tardugno, Celsion’s President and Chief Executive Officer. “This positive opinion on our application for orphan designation status is an acknowledgment of the significant unmet medical need to develop a new treatment for patients with primary liver cancer, a life threatening disorder for which today there is no effective chemotherapeutic standard of care. Centralized approval provides for rapid commercialization across the European Union. We look forward to continuing our positive interactions with the EMA, the FDA and other regulatory agencies around the world to make ThermoDox available to patients as soon as possible.”

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