New Data Continues to Support the Safety and Clinical Activity for Celsion’s ThermoDox(R) in Recurrent Breast Cancer
CELSION CORPORATION (NASDAQ:CLN) today reported that on April 11, 2008 at the meeting of the International Congress of Hyperthermic Oncology, in Munich, Germany, Dr. Zeljko Vujaskovic, Associate Clinical Professor at Duke University, presented early data from 13 patients in a Phase I dose escalation and safety study using ThermoDox to treat patients with recurrent breast cancer on the chest wall. He reported that at doses 20mg/m2 and 30mg/m2 patients showed satisfactory toxicity and promising clinical activity. He further explained that two of the patients treated at the 30mh/m2 dose level have shown a complete local response in the treated area. The study has now enrolled four patients at the 40mg/m2 dose level of which three patients have been treated. Data on the local effect is awaited. These preliminary data are subject to further confirmation at time of study completion.
Dr. Vujaskovic commented, “These results are impressive at this stage in a phase 1 study in such a difficult patient population. Two complete local responses support a clinical ‘proof of principle’ in these patients for whom there is no recognized effective treatment. As such, this elegant technology for localized delivery of a high concentration of doxorubicin, offers hope of a potential treatment option.”
Mr. Michael Tardugno, Celsion’s President and Chief Executive Officer, commented, “This continued demonstration of clinical activity and tumor response in a patient population with few viable treatment options is very encouraging. It supports our optimism that the promise of ThermoDox to effectively treat this difficult disease is well founded. Assuming that the MTD is reached in the third quarter of this year, we would anticipate that our pivotal Phase II study, for which Celsion has received written support from the FDA, will begin as soon as possible thereafter with a goal of enrolling our first patient by year end.”
“This is an exciting time for Celsion, concluded Mr. Tardugno. With encouraging data from our Phase I trials and FDA’s support of a non-randomized registrational study having a primary end point other than survival, we continue to believe that an NDA filing in early 2010 is probable.”
About ThermoDox®: ThermoDox® is Celsion’s proprietary heat-sensitive liposomal encapsulation of doxorubicin, an approved and frequently used anti-cancer drug used in the treatment of various 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.
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.
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.