COLUMBIA, Md., June 8 /PRNewswire-FirstCall/ -- Celsion Corporation (Nasdaq: CLSN) announced today that an abstract on the Phase I/II DIGNITY trial of ThermoDox® in Recurrent Chest Wall (RCW) Breast Cancer was presented at a poster session on June 7, 2010 at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting. The abstract presented the background, rationale, and design of the DIGNITY study, which is ongoing and evaluating ThermoDox in combination with microwave hyperthermia in women with RCW. The ASCO Annual Meeting is being held June 4-8, 2010 at the McCormick Place Convention Center in Chicago, Illinois.
The abstract, titled "Phase I/II study evaluating the maximum tolerated dose, pharmacokinetics, safety, and efficacy of approved hyperthermia and lyso-thermosensitive liposomal doxorubicin in patients with breast cancer recurrence at the chest wall," was presented by Nicholas Borys, M.D., Celsion's Chief Medical Officer, who also addressed questions from attendees of the ASCO conference.
"We are delighted to present the DIGNITY study design and results to date from our RCW breast cancer program. The unique study design provides an innovative pathway to evaluate the safety and efficacy of ThermoDox, and provides a second gateway to NDA approval," commented Michael H. Tardugno, Celsion's President and Chief Executive Officer. "We are grateful for the commitment of our clinical investigators to this important work and we look forward to their on-going participation in the DIGNITY trial."
Dr. Borys commented, "Our Phase I/II trial combines ThermoDox with hyperthermia, offering a unique approach to treating patients with difficult loco-regional recurrence of breast cancer at the chest wall. The poster session was well attended, and I continue to be reminded by clinical experts that this is an unmet need and that our ThermoDox program may help improve the standard of care and quality of life for these patients. Furthermore, we believe that the DIGNITY STUDY may provide the groundwork for applying ThermoDox and hyperthermia in a number of superficial cancers such as melanoma and sarcomas."
About the DIGNITY Clinical Trial
The DIGNITY clinical trial is a Phase I/II open label, dose escalating trial to evaluate the safety and efficacy of ThermoDox® with hyperthermia for the treatment of Recurrent Chest Wall (RCW) Breast Cancer, an aggressive form of cancer with a poor prognosis and limited treatment options. The primary endpoint in the DIGNITY trial is durable complete local response at the tumor site. Once the safe dose is determined Celsion intends to enroll up to 108 patients to establish efficacy. The results from the DIGNITY trial are expected to build on the promising data from the Phase I dose escalation study currently being conducted at Duke University Medical Center.
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. ThermoDox® 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 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 600 patient global Phase III study in primary liver cancer under a FDA Special Protocol Assessment.
Additional information on ThermoDox® clinical studies for RCW breast cancer and primary liver cancer can be found at: www.clinicaltrials.gov.
ThermoDox® is a registered trademark of Celsion Corporation.
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: http://www.celsion.com.
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission.
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