About 93% of the 600 patients in the phase III study of Thermodox are enrolled, Celsion says. Once 190 tumor progression events occur, independent data monitors will unblind the study for an interim analysis to determine whether it can be stopped or if it should continue to the final analysis. Celsion expects this interim look at the Thermodox study to occur in the third quarter. If the study continues to the final analysis, top-line results will be announced in the first half of next year, the company says.
Will Thermodox work? I don't know, honestly. Celsion has animal data proving that Thermodox does accumulate at the tumor site, and when heated, releases high concentrations of doxorubicin above what you'd expect to see if the drug were injected conventionally.
In patients, the Thermodox data collected to date are a bit scarce. A phase I study conducted at two hospitals enrolled 24 patients with either primary liver cancer or cancer originating in other parts of the body that had spread, or metastasized, in the liver. Five different doses of Thermodox were studied.
At the 50 mg. dose -- the dose being used in the phase III study -- time to tumor progression reached 185 days. However, only one patient with primary liver cancer was treated. [Another five patients had metastatic liver disease.] And without a comparator arm in the study, it's difficult to make predictions on how well Thermodox will perform in the much larger phase III study.A couple of things to like about Celsion, if you can stomach the risk of the phase III study: The company, with an enterprise value of around $38 million, is certainly cheap relative to the commercial opportunity for Thermodox, if approved. While you can expect big upside in the stock if the Thermodox study works, watch out for the steep drop if the study fails. I know, that sounds like a ridiculously obvious statement to make, but you'd be surprised how many people fail to consider the downside risk, even in a stock trading at $2.76 a share. The other positive thing about Celsion is that the technology is expandable to cancer in other parts of the body. The company is studying Thermodox in chest wall breast cancer and metastatic liver cancer. Celsion is also exploring next-generation Thermodox molecules that can carry payloads of different chemotherapy drugs.
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