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Celison (CLSN) Meets FDA Requirements for New Drug Application Submission

Celsion Corp. is a leading oncology drug development company focused on treatments using heat energy and heat-activated drug delivery systems. The company today announced it has come to an agreement with the U.S. Food and Drug Administration (FDA) that acknowledges that the company has met requirements for non-clinical studies for its New Drug Application (NDA) for ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin applicable for the treatment of a wide range of cancers.

ThermoDox is currently being evaluated in a 600-patient phase III study at 75 clinical sites to evaluate the drug’s efficacy in combination with radiofrequency ablation (RFA). The FDA previously granted Fast Track Development for the clinical trial, which enables expedited regulatory review and frequent interactions between the FDA.

Per today’s announced agreement with the FDA, Celsion is not required to conduct any additional non-clinical pharmacology, safety pharmacology or general toxicology studies, assuming the results of current phase III studies are adequate. The company said the results of the phase III studies will be reviewed at the time of NDA submission.

“We are very pleased with the FDA’s continued willingness to work closely with the company to identify the most expeditious regulatory pathway forward for ThermoDox in HCC, a life threatening disorder,” Michael H. Tardugno, Celsion’s president and CEO stated in the press release. “Our past consultation with the FDA regarding Chemistry Manufacturing and Controls (CMC) has permitted Celsion to implement and validate process improvements to its manufacturing methods used to produce ThermoDox at commercial scale.”

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