Recent Company Highlights
Initiated the DIGNITY study, an open-label, dose-escalating pivotal Phase I/II study of ThermoDox in combination with hyperthermia to treat recurrent chest wall (RCW) breast cancer
Received orphan drug designation for ThermoDox for the treatment of primary liver cancer; entitles Celsion to seven years of market exclusivity following FDA approval
Published Phase 1 ThermoDox clinical results in primary liver cancer in the peer-reviewed medical journal Expert Opinion on Pharmacology
Celsion’s proprietary thermosensitive liposome technology and ThermoDox was the subject of three presentations at the Society for Thermal Medicine Annual Meeting
Duke University reported promising Phase I interim data evaluating ThermoDox for the treatment of RCW breast cancer
“We have made substantial progress moving our lead oncology drug ThermoDox closer to commercialization,” commented Michael H. Tardugno, Celsion’s president and chief executive officer. “Enrollment in our global Phase III primary liver cancer study is accelerating. We now have 33 clinical sites activated to date, with plans to increase the number of sites to 65 by the end of 2009. We expect to substantially complete patient enrollment in this trial within the first quarter of 2010. Our pivotal Phase I/II recurrent chest wall breast cancer clinical trial is enrolling patients at four clinical sites, and importantly, our first patient has been treated. We expect to complete patient enrollment for this study in the second quarter of 2010. Our financial resources are sufficient to advance our current programs, and we remain focused and are committed to delivering timely clinical results and regulatory approval for ThermoDox and the promise that it holds for treating difficult cancers.”
