Celsion Corporation (CLSN) announced positive results from the phase III HEAT study on ThermoDox, the company’s liposomal delivery system of Johnson & Johnson’s (JNJ) 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.
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 Roche (RHHBY).
Celsion currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Zacks Ranked #1 (Strong Buy) Actelion Ltd. (ALIOF).