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news.Celsion, an oncology drug development company, has received the FDA orphan drug designation for its lead compound, ThermoDox, a heat-activated liposomal encapsulation of doxorubicin, for the treatment of hepatocellular carcinoma.
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ThermoDox is currently being evaluated under a special protocol assessment with the FDA in a 600 patient, global Phase III trial in patients with non-resectable primary liver cancer. Celsion expects to complete patient enrollment for this trial in the first quarter of 2010.
Michael Tardugno, president and CEO of Celsion, said: “We are pleased to receive FDA orphan drug designation for ThermoDox. Orphan drug status is an acknowledgement of the significant unmet need to develop a new treatment for patients with primary liver cancer.
“We look forward to working with the FDA and other regulatory agencies to make ThermoDox available to patients as soon as possible.”