Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, announced today that the first patient has been enrolled in a randomized Phase II study of the Company's lead product candidate, ThermoDox@, a heat-activated liposomal encapsulation of doxorubicin, in combination with diofrequency ablation (RFA) for the treatment of colorectal liver metastases (CRLM).
The multicenter Phase II study is expected to enroll up to 88 patients with colorectal cancer metastasized to the liver. Patients will be randomized to receive either RFA plus ThermoDox@ or RFA alone for the treatment of their liver tumors. Dr. Steven K. Libutti, Professor and Vice Chairman, Department of Surgery and Director of the Montefiore-Einstein Center for Cancer Care at the Montefiore Medical Center and the Albert Einstein College of Medicine in New York City, will serve as the Lead Principal Investigator for the study. In addition to Montefiore, leading research institutions from North America will be included in the Phase II study. The primary study endpoint is based on one year local tumor recurrence, with secondary endpoints of time to progression and overall survival.
"The liver is a common site of metastases for cancers of the colon and rectum, as it provides a favorable environment for their growth and proliferation," stated Dr. Libutti. "Addressing these metastases allows us to improve three- and five-year survival rates among patients with this aggressive disease. While RFA can be effective in treating these tumors, it is often limited to smaller metastases within the liver. Adding ThermoDox@ to RFA as adjuvant therapy is a combination which has demonstrated early clinical promise in treating larger tumors and multifocal disease. I look forward to understanding ThermoDox@'s promise in this larger outcome study."
In the Company's Phase I dose escalation study of 12 patients with non-resectable liver tumors, 8 of whom presented with CRLM, ThermoDox@, in combination with RFA, demonstrated tolerability and a significant dose response relationship. At three months, 45 of the 47 lesions met criteria for a complete response. While not a goal of the study, beyond six months, 16 percent of patients showed a complete response while 33 percent experienced a partial response. The maximum tolerated dose of ThermoDox@ was established at 50 mg/m.
"Now that Celsion's Phase III HEAT Study of ThermoDox@ in primary liver cancer has successfully completed its interim efficacy analysis, the expansion of our ThermoDox@ program into other areas of promise is a priority for the Company," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Colorectal cancer is among the most prevalent cancers worldwide, and a leading killer among cancers in Europe and the United States. Checking progression of this disease in the liver is an important clinical goal and the primary outcome measure of this study." Mr. Tardugno added: "CRLM represents a significant commercial opportunity, and we look forward to the results of this trial around the time ThermoDox@ approaches registration, following a positive outcome in the HEAT Study."