Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate.
Earlier in the week, Celsion Corporation (NASDAQ: CLSN) received regulatory clearance to initiate the phase III OPTIMA study on ThermoDox in Taiwan, Hong Kong, South Korea and Canada. ThermoDox is the company's liposomal delivery system of Johnson & Johnson's (NYSE: JNJ) Doxil (doxorubicin).
The study will evaluate ThermoDox in combination with radiofrequency ablation (RFA), versus standardized RFA alone, for the treatment of hepatocellular carcinoma (NYSE: HCC), the most common type of liver cancer. The primary objective of the study is overall survival (OS). Celsion expects to enrol around 550 patients around the globe for the study.
The OPTIMA study is already cleared in the U.S. Moreover, Celsion has filed Clinical Trial Applications in countries like the Philippines and Thailand, and also a request for a Voluntary Harmonization Procedure (VHP) in Europe. The VHP request provides assessment of multinational clinical trial applications across various EU countries like Germany, France and Spain.
The company also plans to meet the European Medicines Agency later in the year to discuss the trial design for ThermoDox and its registrational strategy. Celsion is primarily focused on the OPTIMA study. The company intends to initiate the study in mid-2014. We expect investor focus to remain on updates regarding the OPTIMA study.
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 believe that the successful development of ThermoDox will be crucial for the financial performance of Celsion in the long run. 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) Gilead Sciences (NASDAQ: GILD).
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