FDA Win Sends Celsion Corporation (CLSN) Shares Higher

Celsion Corporation (NASDAQ:CLSN) shares were gaining on Thursday as the company passed a regulatory hurdle.

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The U.S. Food and Drug Administration (FDA) has approved the company’s plans to initiate its OVATION II Study for a DNA-based immunotherapy that’s designed to locally treat ovarian cancer called GEN-1. The company’s Medical Advisory Board helped to develop the Phase I/II trial for Celsion’s drug.

The study follows a very promising clinical trial from the Phase IB dose-escalating OVATION Study that saw patients receiving escalating doses of GEN-1 at various doses for eight treatments total. These were combined with a type of chemotherapy and surgery.

The upcoming Phase I/II study from Celsion will begin with a single dose escalation to a higher dose than before in order to help determine what a safe and tolerable dose of the treatment would be, including the study of how an immune system responds to such a dose.

Up to 90 patients with Stage III or IV ovarian cancer will be examined through the study at up to 15 U.S. centers. The study is expected to show a 33% improvement in the main goal, which is a progression-free survival (PFS) compared to other treatments.

The first phase of the study examined 13 patients, and four of these progressed from the escalating doses that were provided to them.

CLSN shares gained more than 4.2% as of Thursday afternoon.

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