Celsion is developing a procedure to deliver high doses of chemotherapy directly to the site of cancer using tiny, heat-sensitive spheres of fat containing a payload of the chemotherapy drug doxorubicin. When injected into the body, Thermodox accumulates at the site of the tumor, and when the tumor site is heated to about 107 degrees using radio waves (radiofrequency thermal ablation, or RFA), the Thermodox spheres melt, bathing the tumor and adjacent tissue in high levels of doxorubicin.Celsion is conducting a phase III study in which 600 patients with hepatocellular carcinoma, also known as primary liver cancer, are being treated with Thermodox plus RFA or RFA alone. An interim analysis is expected in the third quarter. A paucity of early-stage Thermodox data exists to help predict whether the phase III study will succeed. A phase I study conducted at two hospitals enrolled 24 patients with either primary liver cancer or cancer originating in other parts of the body that had spread, or metastasized, in the liver. At the 50 mg dose of Thermodox -- the dose being used in the phase III study -- time to tumor progression reached 185 days. However, only one patient with primary liver cancer was treated.
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