Disappointing Trial Results Released, Celsion Stock Plummets

ThermoDox, Celsion Corporation’s promising liver cancer treatment that had dramatically buoyed stock prices, has now also led to its demise on the market. Shares dropped by more than 80 percent during the first hour of trading on Thursday after reports came of the experimental drug’s failure to live up to expectations in a Phase III clinical trial.

Results were “not even close” to meeting the trial’s goals, CEO Michael Tardugno said on an investor conference call. "I don't believe the data will support (marketing) registration in any of the major markets.”

During 2012, Celsion’s stock more than tripled in price in anticipation of ThermoDox’s success. Developed in partnership with Duke University, the Food and Drug Administration had awarded the drug technology a fast-track designation in August 2010.

Celsion Heat Trial Data in January

The trial, named HEAT, illustrated how ThermoDox used a liposome to deliver a commonly used chemotherapy drug, doxorubicin, directly to tumors. Locally applied heat therapy would then release the drug, increasing its effectiveness. In an unexpected twist, the treatment did not provide better results when compared to radiofrequency ablation, where tumors are destroyed using electricity.

The news comes just a week after a partnership was announced between Celsion and leading Chinese pharmaceutical company Zhejiang Hisun Pharmaceutical Company. Celsion had already received an initial payment of $5 million.  

The future value of ThermoDox will be further analyzed using data from the trial, and will continue to be tested in mid-stage studies to treat breast and colorectal cancers.