) 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
The DMC, after its review, recommended that the HEAT study can
be continued as per schedule. Top-line data from the study is
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
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
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
Onyx Pharmaceuticals, Inc.
) Nexavar and
We currently have a Neutral recommendation on Celsion. The stock
carries a Zacks #2 Rank (Buy rating) in the short run.
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