CELSION CORPORATION (AMEX: CLN) today announced that it had received a supportive written response from the FDA in relation to its proposed registrational study for use of ThermoDox in patients with recurrent breast cancer at the chest wall. With these FDA responses, Celsion now believes it has established a Phase II protocol which has defined acceptable endpoints in a defined patient population that has an unmet medical need. Celsion intends to proceed with its plans for initiating the Phase II study in the second half of 2008. It is anticipated that the open label study will enroll up to a maximum of 100 patients in approximately ten US centers.
Mr. Michael H. Tardugno, Celsion’s President and Chief Executive Officer added, “The response from the FDA confirms our belief and that of our medical consultants that this is a patient population with an unmet medical need. Accordingly, with appropriate supporting data, we may be able to seek an early approval for ThermoDox for this indication, and are designing this Phase II as a Pivotal Study.”
ThermoDox is currently involved in a Phase I Dose escalation study at Duke University. This study continues to enroll patients and show promising data as previously reported at the WICO/STM meeting in Washington and the ESHO in Prague in early 2007. The study is currently in the process of being expanded to include an additional site with the intent of accelerating study enrollment.
About Celsion: Celsion is dedicated to the development and commercialization of oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat activated drug delivery systems.
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, North Shore Long Island Jewish Health System.
Celsion has also developed a microwave based system, the Prolieve Thermodilatation® system, for the treatment of benign prostatic hyperplasia which is marketed in the United States under an exclusive distribution agreement with Boston Scientific Corporation. 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.