Leading oncology drug development company Celsion Corp. today announced it has enrolled its first patient in a randomized phase II study of ThermoDox, the company’s lead product candidate. ThermoDox is a heat-activated liposomal encapsulation of doxorubicin that, in combination with radiofrequency ablation (RFA), is being tested for the treatment of colorectal liver metastases (CRLM).
Up to 88 patients diagnosed with colorectal cancer metastasized to the liver are expected to be enrolled in the multicenter phase II study. The patients will be randomized to receive liver tumor treatment that is either includes RFA plus ThermoDox or RFA alone. Leading North American research institutions will be included in the phase II study, including Montefiore-Einstein Center for Cancer Care in New York City, which is where Lead Principal Investigator Dr. Steven K. Libutti serves as director.
More than 141,000 new cases of colorectal cancer were diagnosed in 2010, with 51,000 colorectal cancer deaths, according to the American Cancer Society. As many as 25 percent of colorectal cancer patients present with liver metastases, and 50 percent develop liver metastases within five years. The liver provides a favorable environment for growth and proliferation of metastases for cancers of the colon and rectum, and addressing these metastases enables improvement of three- and five-year survival rates for patients with this type of cancer. RFA alone is often limited to treating smaller metastases within the liver, but the addition of ThermoDox as adjuvant therapy has shown early clinical promise in treating larger tumors and multifocal disease. The primary endpoint of the phase II study is based on one year local tumor recurrence, with secondary endpoints of time to progression and overall survival.
Celsion Corp. is a leading oncology company specializing in the development and commercialization of cancer drugs. Celsion has research, license and commercialization agreements with such leading institutions as the National Institutes of Health, Duke University, University of Hong Kong, UCLA Department of Medicine, the University of Pisa, Kyungpook National University Hospital, and the Beijing Cancer Hospital.
For further information about the company, visit www.celsion.com
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