FDA grants Fast Track Designation to Celsion's ThermoDox for liver cancer treamtment

Celsion CorporationAug 25 2010

Celsion Corporation (Nasdaq: CLSN), a leading oncology drug development company, today announced that the U.S. Food and Drug Administration (FDA) has designated the HEAT Study of its investigational drug, ThermoDox®, in combination with radiofrequency ablation (RFA), as a Fast Track Development Program.  ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, is currently being evaluated under a Special Protocol Assessment (SPA) agreement with the FDA in a 600 patient global Phase III trial in patients with non-resectable hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer.  With nearly 70% of patients enrolled in the trial, Celsion is targeting to complete patient enrollment by year end 2010.

"We are very pleased to receive the Agency's Fast Track Designation for ThermoDox," stated Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer.  "Fast Track Designation is an acknowledgement that HCC is a significant unmet medical need representing a life threatening disorder.  It also recognizes the challenges facing pharmaceutical companies to develop effective new treatments for this difficult disease.  Together with the FDA's SPA agreement, granting accelerated review for the HEAT Study, the Fast Track status provides Celsion with the shortest time to approval.  Supported further by the National Cancer Institute's recent designation of the HEAT Study as a Priority Clinical Trial, it is clear that the major U.S. healthcare agencies and the liver cancer medical community recognize the potential of ThermoDox. We look forward to working with the FDA and other regulatory agencies around the world to make ThermoDox available to patients as soon as possible."

The FDA's Fast Track Development Program provides for expedited regulatory review for new drugs that treat serious or life threatening diseases which are not satisfactorily treated by existing therapies, or for drugs that provide a significant advantage over existing therapies for serious diseases.  Under the Fast Track Designation, Celsion is now eligible to submit a U.S. New Drug Application (NDA) on a rolling basis.  This permits the FDA to review sections of the NDA in advance of receiving the complete submission.