) announced positive results from the phase III HEAT study on
ThermoDox, the company's liposomal delivery system of
Johnson & Johnson
) Doxil (doxorubicin), for primary liver cancer. The phase III
HEAT study is evaluating ThermoDox in combination with
radiofrequency ablation (RFA) for the treatment of hepatocellular
carcinoma (HCC), the most common type of liver cancer.
The primary objective of the study is progression-free survival.
The study is conducted under the U.S Food and Drug
Administration's (FDA) Special Protocol Assessment (SPA). Data
from the study revealed that ThermoDox significantly improves
overall survival (55%) in patients whose lesions underwent RFA
treatment for a minimum of 45 minutes.
The subgroup included 283 patients. The other subgroup (n=167)
of the HEAT study included patients on ThermoDox whose lesions
underwent RFA treatment for less than 45 minutes.
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This is a significant turnaround for Celsion, as far as ThermoDox
is concerned. In Jan 2013, the company announced that the HEAT
study failed to meet its primary endpoint of progression-free
survival. Meanwhile, Celsion is in discussions with the FDA and
other regulatory authorities around the world regarding a pivotal
phase III study on ThermoDox. The pivotal study is expected to be
initiated by Jun 30, 2014.
We note that Celsion is evaluating ThermoDox in other forms of
cancer treatment as well. ThermoDox is currently in a phase II
study for the treatment of recurrent chest wall breast cancer.
We are encouraged by the recent data on ThermoDox. We believe
that the successful development of ThermoDox is crucial for the
financial performance of Celsion in the long run. Moreover, the
oncology market looks extremely competitive with the presence of
big players like
Celsion currently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks include Zacks Ranked #1 (Strong Buy)