The DSMB for the DIGNITY Trial is comprised of an independent group of medical experts who are responsible for reviewing and evaluating patient safety and efficacy data. The DSMB reviews safety data at regular intervals with the mandate to ensure patient safety and monitor the quality of the study. The study design for the Phase I/II ThermoDox trial incorporates a planned increase in dosage, from 40 to 50mg/m2 if supported by safety data.
"We are pleased that, after its review, the DSMB has recommended continuation of the study at the 50mg/m2 dose," stated Michael H. Tardugno, President and Chief Executive Officer of Celsion. "Should 50mg/m2 demonstrate safety in the next 6 patients, it will be established as the maximum tolerated dose (MTD) for continuation at Phase II portion of the trial. We are hopeful to provide our data set confirming the MTD trial by the end of this year."
Celsion's Phase I/II ThermoDox study for Recurrent Chest Wall Breast Cancer (RCW) will enroll about 109 patients in a single arm trial. The trial is designed to evaluate the potential for ThermoDox in combination with hyperthermia to provide local control of superficial breast cancer recurrence. The primary end point is durable complete local response (DCLR). FDA has indicated that the trial may be considered pivotal, pending a review of the data supporting the endpoint. The trial is recruiting patients at 5 sites in the US including New York University, The Rhode Island Hospital, St Barnabus Medical Center, Virginia Commonwealth University Medical Center, and the Florida Cancer Institute.
The design of the DIGNITY Trial builds upon the promising data from the Phase I dose escalation study currently being conducted at Duke University Medical Center. To date, at Duke University Medical Center, RCW breast cancer patients have been treated with ThermoDox at doses ranging from 20 mg/m2 to 40 mg/m2. A study update was provided by Duke at the April 2009 Society for Thermal Medicine Conference. Investigators, Ellen Jones, MD and Zeljko Vujaskovic, MD, PhD, reported that ThermoDox has demonstrated clinical activity in the evaluable patients. Additionally, the investigators noted that ThermoDox combined with hyperthermia offers a potential treatment option for RCW breast cancer and that the activity to date suggests the combination of ThermoDox plus hyperthermia improves anti-tumor effects on the chest wall when compared to non-liposomal chemotherapy alone. A copy of the Duke presentation announcing the Phase I interim data can be found on the Company's website at www.celsion.com.
"The DIGNITY Study investigators are comprised of some of the finest breast cancer researchers in the nation and their commitment to our study has been remarkable," noted Nicholas Borys, MD, Celsion's Chief Medical Officer. "Our immediate goal is to raise awareness in the breast cancer community of this important study in order to fully enroll the DIGNITY Study by end of 2011."
Additional information on the Phase I/II ThermoDox clinical study may be found at www.clinicaltrials.gov.
ThermoDox(R) 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. ThermoDox(R) is administered intravenously and in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. Localized mild hyperthermia (39.5-42 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 already demonstrated remarkable evidence of clinical activity in Phase I studies for primary liver cancer and recurrent chest wall breast cancer. For the primary liver cancer indication, Celsion has been granted FDA Orphan Drug designation. For recurrent chest wall breast cancer, ThermoDox(R) is being evaluated in a pivotal Phase I/II open-label, dose-escalating trial that is designed to measure durable local complete response at the tumor site.
ThermoDox(R) is a registered trademark of Celsion Corporation
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.
Celsion is dedicated to the development and commercialization of innovative oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has licensed ThermoDox(R) to Yakult-Honsha for the Japanese market and has a partnership agreement with Phillips Medical to jointly develop its heat activated liposomal technology in combination with high intensity focused ultrasound to treat difficult cancers. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System.
For more information on Celsion, visit our website: www.celsion.com.