Celsion Reports on ThermoDox(TM) at American Society of Clinical Oncology Gastrointestinal Symposium
Monday January 22, 9:04 am ET
Researchers Report That 22 Patients Have Been Treated in a Phase I Study Using ThermoDox in Combination with Radiofrequency Ablation to Treat Patients with Unresectable Hepatic Malignancies with No Unexpected Toxicity
COLUMBIA, Md.--(BUSINESS WIRE)--CELSION CORPORATION (AMEX:CLN - News) today reported that Dr. Bradford J. Wood, Chief, Interventional Radiology Research at the National Institutes of Health's National Cancer Institute presented the progress of a Phase I dose escalation study, using ThermoDox, to treat unresectable liver cancer. ThermoDox, a heat activated liposomal formulation of doxorubicin, in conjunction with Radiofrequency Ablation (RFA) was used with limited and manageable toxicity to treat 22 patients, 8 with primary hepatocellular carcinoma and 14 with metastatic liver cancer, at doses of up to 60 mg/m2. The study is being performed at the National Cancer Institute (NCI) as part of a Cooperative Research and Development Agreement (CRADA), under the leadership of Dr. Wood and Dr. Steven K. Libutti, Senior Investigator, Head, Tumor Angiogenesis Section, Surgery Branch, CCR, NCI; and at Queen Mary Hospital in Hong Kong under the leadership of Dr. Ronnie T.P. Poon, MD, Professor of Surgery, Faculty of Medicine at Queen Mary Hospital, University of Hong Kong. Dr. Wood presented the abstract and poster at the ASCO-GI meeting in Orlando, Florida.
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In the study, patients with up to 4 lesions ranging from 3 to 7 centimeters are eligible to receive ThermoDox at doses ranging from 20 to 70 mg/m2. The effect of the treatment on the diameter of the lesions is followed using MRI, PET and contrast enhanced CT scans taken pre-treatment and at one and three months post-treatment. Lesion diameters will be compared to those of other patients treated with RFA alone. This study, being carried out by Celsion and the NCI continues to enroll patients into the 60 mg/m2 treatment cohort.
Celsion has licensed the global rights to the temperature-sensitive liposome technology from Duke University where ThermoDox is also being used in this Phase I clinical study of patients with recurrent chest wall breast cancer under the care of Dr. Kim Blackwell, the principal investigator.
Dr. William Hahne, Celsion's Vice President of Research and Development, commented "We are pleased that dose in this study continues to escalate safely as clinical evidence suggests that a higher dose should result in increased efficacy. We are continuing to work with the FDA to finalize endpoints for a Phase III study in primary liver cancer, to be conducted by Celsion, in which we expect to initiate enrollment in 2007. This work will be used to refine tumor targeting and ultimately to improve the efficacy of drugs using our heat activated delivery system."
