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news.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 (ODD) for Celsion's ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, for the treatment of hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer.
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ThermoDox is a proprietary heat-activated liposomal encapsulation of Doxorubicin.
Celsion said that ThermoDox is currently being evaluated under a special protocol assessment with the US Food and Drug Administration (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.
ThermoDox has previously received ODD from the FDA.
Celsion president and CEO Michael Tardugno said that they were pleased to receive a positive opinion from the Committee for Orphan Medicinal Products, which immediately precedes final ODD from the EMA, for ThermoDox.
"This positive opinion on our application for orphan designation status is an acknowledgement of the significant unmet medical need to develop a new treatment for patients with primary liver cancer," Tardugno said.
"We look forward to continuing our positive interactions with the EMA, the FDA and other regulatory agencies to make ThermoDox available to patients as soon as possible."