Celsion announces promising trial results for ThermoDox in breast cancer

Celsion Corporation has announced that promising Phase I clinical results evaluating ThermoDox for the treatment of recurrent chest wall (RCW) breast cancer were presented by Duke University investigators on Sunday, April 5 at the 2009 Annual Meeting of the Society for Thermal Medicine (STM) in Tucson, Arizona.

Duke University Medical Center, Department of Radiation Oncology, Clinical Associate Professors Ellen Jones, PhD, MD, and Zeljko Vujaskovic, MD, PhD presented results from the Phase 1 study being conducted at Duke University Medical Center under the leadership of Kimberly Blackwell, MD, Division of Medical Oncology, through a grant jointly sponsored by Celsion and the National Institutes of Health. This Phase I study is designed to determine the maximum tolerated dose of ThermoDox when used in combination with microwave hyperthermia to treat mastectomy patients with RCW breast cancer.

To date sixteen patients have been treated with ThermoDox at doses ranging from 20 mg/m² to 40 mg/m². ThermoDox has demonstrated positive clinical activity in all of the evaluable patients.

"Based on the current data from our Phase I study that was presented at the STM, we are encouraged by the preliminary results of ThermoDox for the treatment of RCW breast cancer and look forward to determining the maximum tolerated dose and taking ThermoDox into the next stages of development," stated Ellen Jones PhD, MD, co-investigator at Duke University Medical Center. Zeljko Vujaskovic, MD, PhD, at Duke University Medical Center and also a co-investigator for the study, added, "I am optimistic regarding the data that has been presented on microwave hyperthermia combined with ThermoDox. We are eager to learn more about this novel approach to treating women with RCW breast cancer."

Michael H. Tardugno, Celsion's President and Chief Executive Officer, commented, "We are pleased that the oncology team at Duke University Medical Center fully supports the continued development of ThermoDox. RCW breast cancer is a debilitating disease for afflicted women. We are grateful for their commitment to this important work and look forward to their participation in our on-going Phase I/II pivotal study. With our current cash balance and the June 2009 $15 million payment from Boston Scientific for the purchase of Celsion's medical device assets, we believe that Celsion has the funds sufficient to fully enroll this important trial."

Concurrent with the Duke Phase I study, Celsion has commenced a pivotal Phase I/II open-label trial for ThermoDox in the treatment of RCW breast cancer that is designed to measure durable local complete response at the tumor site. Celsion expects to enroll approximately 100 patients in the United States and to complete the Phase I portion of the study this year. Additional information on the study may be found at http://www.clinicaltrials.gov.

About Breast Cancer Recurrence at the Chest Wall

Depending on risk factors, up to 40% of women with mastectomies may experience breast cancer recurrence at the chest wall. The disease is a highly aggressive form of cancer and is generally defined as the recurrence of tumor to the area of the initial definitive treatment such as mastectomy. There are a significant number of women diagnosed with breast cancer recurrence at the chest wall that have exhausted all treatment options and cannot be treated with further surgical resection, radiation, or existing chemotherapy.

About ThermoDox

ThermoDox in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. ThermoDox is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.

ThermoDox has also demonstrated evidence of efficacy in a Phase I study for primary liver cancer. Celsion has been granted FDA Orphan Drug designation for ThermoDox and is conducting a pivotal global Phase III study in primary liver cancer under a FDA Special Protocol Assessment.