Celsion Corporation (CLSN - Snapshot Report) recently announced that the independent Data Monitoring Committee (DMC) completed its last intermediate review of the pivotal phase III HEAT study being conducted with ThermoDox for hepatocellular carcinoma (HCC).
The DMC, after its review, recommended that the HEAT study can be continued as per schedule. Top-line data from the study is expected shortly.
The phase III HEAT study is evaluating ThermoDox in combination with radiofrequency ablation (RFA) for the treatment of HCC. The primary objective of the study is progression-free survival (PFS).
The study is conducted under the US Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA). The study has received Fast Track Designation and was declared as priority trial for liver cancer by the National Institutes of Health.
In May this year, Celsion completed the enrollment process for the study. The independent DMC reviewed 701 enrolled patients in the trial. For unblinding and planned final analysis of the study, a total of 380 PFS events are required, which Celsion expects to achieve by year-end.
ThermoDox enjoys orphan drug designation both in the US and the EU. We remind investors that in December 2011, the European Medicines Agency (EMA) stated that Celsion can submit a marketing authorization application (MAA) on the basis of results from the HEAT study.
The HEAT study is being conducted in the US, Canada, Italy, China, Taiwan, Hong Kong, Korea, Thailand, Malaysia and the Philippines. Celsion is also looking for additional indications of the candidate including other tumors.
Currently, the HCC market has drugs like Bayer AG (BAYRY - Analyst Report)/Onyx Pharmaceuticals, Inc.’s Nexavar and Pfizer Inc.’s (PFE - Analyst Report) Sutent.
We currently have a Neutral recommendation on Celsion. The stock carries a Zacks #2 Rank (Buy rating) in the short run.