Updated with new information.
Here I thought Celsion was doing the honorable thing by making no excuses for the failure of its Thermodox liver cancer therapy. Last January, CEO Michael Tardugno told investors, straight up, that data from the Thermodox phase III study weren't close to being strong enough to support approval filings in the U.S. or Europe. He didn't offer any spin, he didn't try to data-mine results seeking a desperate glimmer of hope. Thermodox failed and that was that.
All that goodwill was thrown away Tuesday. Celsion now says a "post analysis" of the failed phase III study shows Thermodox did shrink liver tumors in a subgroup of patients who underwent radio-frequency ablation (RFA) for at least 45 minutes. [Pity the poor patients who only had their liver tumors cooked for 44 minutes, apparently.]This is not just ordinary data-mining. This is data-mining so deep and ridiculous that Celsion may need to list itself on the Shanghai stock exchange. "We have completed a thorough review of the HEAT Study and there is clear evidence that ThermoDox can benefit patients when RFA is optimized," said Celsion's chief medical officer Nicholas Borys, in a statement. Too bad the press release didn't come with a laugh track attached. The graph below, which comes directly from a previous Celsion presentation of Thermodox clinical data, explains why the "45 minute RFA" subgroup analysis is a complete farce. Credit for finding this slide goes to biotech investor David Sobek of Sobek Analytics. You can and should follow Sobek on Twiter at @dsobek. What you're looking at is the pharmacokinetics of Thermodox. In other words, how much Thermodox (i.e. doxorubicin) gets into a patient's bloodstream following RFA treatment. What you see, clearly, from the graph is patients get the vast majority of Thermodox in the first 45 minutes of RFA treatment. If this is true, then extending RFA treatment beyond 45 minutes is futile and Celsion's spin-job is ludicrous. Of course, we all know what's going on here. Celsion executives are staring at the end of their careers, so they're desperate to prevent the compensation spigot from being turned off. Celsion has $46 million dollars left to spend, so better that money be funneled into the bank accounts of Tardugno and his crew instead of being returned to shareholders or creditors. Celsion fired one-third of its workforce today, thereby reducing overhead even further and preserving more money for executive salaries. Even better if Celsion can actually fool new investors into providing more funding. If that happens, the Thermodox charade might be extended indefinitely. Hell, Tardugno might even convince his sycophantic board of directors to pay him a cushy bonus. I hoped Celsion would be different. Instead, the actions of its executives are just shameless. -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein
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