ThermoDox is currently being assessed under a Special Protocol Assessment with the US Food and Drug Administration in a 600 patient pivotal Phase III trial, the HEAT study, in patients with non-resectable primary liver cancer.
In the HEAT study, ThermoDox is administered intravenously in combination with RFA.
Celsion president CEO Michael Tardugno said EC’s orphan drug designation for ThermoDox recognizes the urgent need for new therapies in addressing primary liver cancer, a rapidly progressing disease and for which few effective treatment options exist.
"As the HEAT study nears enrollment completion and we look to its outcome, this designation, along with US orphan drug status, FDA Fast Track designation and regulatory agency support in 11 countries worldwide for our Phase III HEAT study, provides us with speed and strategic flexibility both through the registration process and in the commercial setting," Tardugno said.