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Celsion’s Stock Falls 81%

February 1, 2013

One of the last catalysts before a final FDA decision, comes from a drug’s Phase III clinical trial data. Positive trial results can result in shares popping. There is also the reverse situation of failed clinical trial results causing shares to sink. Thus, late Phase clinical trials is one of the most critical steps of the orphan drug development life cycle. This is the critical time where demands for data on the drug’s safety and efficacy, comparisons to competitors, and other factors are important.

Just a few days ago, the Orphan Druganaut Blog used Celsion’s orphan drug ThermoDox in a case study to illustrate how important Phase III clinical trial data is for affecting a company’s stock movements. There can be big stock moves, either up or down based on Phase III clinical trial data being released.

Celsion Corporation announces on January 31, 2013, that the Phase III HEAT Study data of orphan drug ThermoDox for primary liver cancer did not meet the primary endpoint. ThermDox “did not meet the goal of demonstrating persuasive evidence of clinical effectiveness that could form the basis for regulatory approval ….”. The HEAT Study evaluates Celsion’s drug for Hepatocellular Carcinoma (HCC), using encapsulated Doxorubicin and Radio Frequency Ablation (RFA) for delivering the drug to the targeted treatment site – the liver. ThermoDox did not slow liver tumor growth in the final stage of testing.

According to Beta.fool.com, shares of Celsion gains 350% in 2012. Per Bloomberg, the stock fell 81% at the close in New York on January 31, 2013. It is the biggest single-day decline since the shares began trading in April 1994.

ThermoDox has received Fast Track and Priority Review designations from the FDA. ThermoDox has orphan drug designations for HCC in the US and Europe.

Per a December 2012, DailyFinance.com article, Celsion has a “Year-To-Date Performance of 335.88%” as a result of the anticipated release of the Phase III HEAT clinical trial data.

The Internet is buzzing on the stock’s tremendous nosedive :

1)  The Wall Street Journal article titled, “Celsion Shares Plunge on Drug’s Trial Failure”

2)   SeekingAlpha.com article titled, “Celsion Phase III Failure: What Went Wrong ?”

3)    SeekingAlpha.com article titled, “Can Celsion survive after imploding over Phase III results ?”.  

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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