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So what: Celsion's late-stage trial, known as HEAT, was designed with an endpoint of showing a 33% improvement in progression-free survival. Ultimately, the control arm performed 20% better than expected, while ThermoDox actually performed worse than the control arm ... ouch! ThermoDox, which uses a liposome to transport a chemotherapy agent to the site of a tumor, is currently also being tested in mid-stage trials for breast cancer.
Now what: It would be one thing if ThermoDox just missed the PFS target, or if it had a pipeline full of other candidates. Unfortunately, Celsion was mortgaging the house that ThermoDox would be its white knight, and that didn't turn out to be the case. Given the awful results today, I'm not very hopeful that its mid-stage breast cancer trials will be effective, and would suggest steering clear of Celsion until further notice.
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