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.