Clinical Activity for Celsion’s Thermodox® Reported

Note: Article adapted from a news release issued by Celsion.

Columbia, MD – Early results from a Phase I clinical study of ThermoDox for treating patients with recurrent breast cancer on the chest wall revealed that after only two cycles of a low-dose, six-cycle regimen, six patients showed early signs of clinically meaningful activity, according to a release issued by Celsion Corporation. One patient had a complete response in the treated area, two patients had a partial response and three had stable disease following treatment, Duke University Medical Center's Zeljko Vujaskovic reported at the joint meeting of the World Congress on Interventional Oncology and the Society of Thermal Medicine on May 16, 2007.

ThermoDox is Celsion’s proprietary heat-sensitive liposomal encapsulation of doxorubicin, an approved and frequently used anti-cancer drug used in the treatment of various forms of the disease, including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology-- invented in 1996 by David Needham, a professor in the mechanical engineering and materials science department at Duke's Pratt School of Engineering--enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor. (Learn more about liposomes.)

“These results are unusual at this early stage in a study," Vujaskovic said. " A complete response at such a low dose indicates a biological 'proof of principle' in these patients for whom there is no recognized standard of care. As such, this elegant technology for localized delivery of a high concentration of doxorubicin offers hope for a potential treatment option in the future.”

Kimberly Blackwell, also of Duke Medical Center, continues to enroll patients in this study which is intended to provide the dosage to be used in a Phase II study, which Celsion expects to initiate early next year. “The few patients reported on to date have tolerated the treatment well and there have been no unexpected reactions," Blackwell said. "The clinical activity demonstrated in this small number of patients suggests that the combination of ThermoDox and localized hyperthermia may have potentially clinically important anti-tumor activity on the chest wall. However, larger studies will be necessary in order to determine its ultimate safety and effectiveness.”

Added Michael Tardugno, Celsion’s President and Chief Executive Officer, “This early demonstration of clinical activity and tumor response in a patient population with few viable treatment options is very encouraging. Moreover, these early data confirm our belief that the localized delivery of high concentrations of chemotherapy in short time intervals through a combination of ThermoDox and mild hyperthermia will be effective in treating solid tumors.”

"It's a moment me and my Mum have been waiting for--demonstration of the ability of this drug device combination to actually treat cancer in humans," Needham said. Needham's mother had breast cancer and a mastectomy in 1972, inspiring Needham's commitment in 1978 to work on the development of a new cancer treatment.

"I always said, even if just one person benefits, it will have been worth it," he said.

Duke University Medical Center is currently enrolling patients in the above Phase I study. Patients who may be interested in enrolling in the study should contact the Duke Protocol office at (919) 660-1278 or visit the Duke hyperthermia website.