Thursday, January 31, 2013 11:38:24 AM
UPDATE: Celsion Shares Plunge on Drug's Trial Failure
2 minutes ago - Dow Jones News
(Adds details, company and analyst comment, and updated stock price.)
--Late-stage trial failure calls into doubt Celsion Corp.'s cancer drug technology
--Shares plunge more than 80% after tripling in last year
--Company says the study results were 'not close' to achieving trial's goal
By Joseph Walker
Celsion Corp. (CLSN) said its experimental drug technology failed to significantly slow the progression of liver cancer, failing to meet its primary goal, in a late-stage trial.
The failure called into doubt the near-term viability of Celsion's cancer drug, ThermoDox, which is also being studied in two mid-stage trials.
Shares plunged 81% to $1.52. Through Wednesday's close, shares had more than tripled over the past year to $8.38.
Celsion didn't release data from the trial but suggested the drug missed its goal by a wide margin. The trial sought to achieve a significant extension in the time that liver-cancer patients' survived without their diseases advancing.
"It was not close," Chief Executive Michael Tardugno said. "There was a modest improvement."
The Lawrenceville, N.J., biotechnology company said it will undertake a strategic review to assess the future of ThermoDox. It said it has about $27 million in cash and investments, which will carry it through this year and "well into 2014."
The company said it will consider following the currently enrolled patients to evaluate the secondary endpoint of overall survival.
ThermoDox is a form of the chemotherapy liposomal doxorubicin which, when activated by heat, delivers therapy directly to tumors.
"We know the mechanism of action is reliable," Mr. Tardugno said of the technology. "Whether or not that is of clinical value, we have a little more work to do."
The trial, known as the HEAT study, compared the use of ThermoDox in combination with radiation treatment versus radiation alone in liver-cancer patients.
Celsion said a mid-stage study of ThermoDox in breast cancer would continue to enroll patients. However, a mid-stage study in colon cancer that has spread to the liver would have to be re-evaluated after the failure disclosed Thursday.
"Given that the HEAT trial result was unimpressive enough to keep private, we can no longer have any confidence in other trial results," said Jonathan Aschoff, an analyst at Brean Capital LLC.
The study failure will make enrolling patients in subsequent trials difficult, Mr. Aschoff said, and "even if enrolled, a similar outcome will occur in future trials."
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