Liver Cancer

CELSION Provides Update on Status of Special Protocol Assessment (SPA) Submission

Liver Cancer Library Library Home This article was published in Biotech Business Week, which you can subscribe to online.

Celsion Corporation has received comments this morning from the FDA regarding its September request for a special clinical protocol assessment for its study, "A Phase III, Randomized, Double-Blinded, Dummy-Controlled Study of the Efficacy and Safety of ThermoDox in Combination with Radiofrequency Ablation Compared to RFA-Alone in the Treatment of Non-Resectable Hepatocellular Carcinoma." The comments from the FDA requested clarifications and recommendations to the study protocol and monitoring. On initial review, Celsion expects to satisfactorily address all of FDA comments and re-submit the protocol for formal special protocol assessment promptly.

"While we are disappointed that another review will be required", commented Michael H. Tardugno, president and chief executive officer of Celsion, "We recognize that the approval mechanism is iterative in nature. We believe the response made by FDA to our submission should not require any significant revisions to the study design. We will continue to work collaboratively with FDA with the intent of starting our study early next year."

The Company expects to discuss FDA's comments and its plans going forward during its third quarter conference call. The Company expects to announce the date and time of its conference call later today.

Keywords: Hepatocellular Cancer, Hepatocellular Carcinoma, Liver Cancer, Liver Carcinoma, Oncology, Regulatory Actions, Celsion Corporation.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2007, Biotech Business Week via NewsRx.com.