Thermodox
 

Baltimore Business Journal - December 15, 2008
http://baltimore.bizjournals.com/baltimore/stories/2008/12/15/daily1.html
Monday, December 15, 2008 - 1:18 PM EST
Celsion Corp., Yakult Honsha Co. to partner on cancer drug in Japan

Baltimore Business Journal - by Sue Schultz Staff

Celsion Corp. has inked a $20.5 million licensing deal to commercialize a cancer drug in Japan.
Under the agreement — unveiled Monday with Tokyo-based Yakult Honsha Co., Ltd. — Celsion would get $2.5 million upfront and an additional $18 million when the drug is approved by the Japanese Ministry of Health, Labor and Welfare. The Japanese company would also be responsible for clinical trials of the drug in Japan.
The drug, ThermoDox, developed by the Columbia-based biotech to treat cancer, is in Phase III clinical trials in the U.S. for liver cancer and in Phase II trials for recurrent chest wall breast cancer.
“This achievement is an example of the commitment of our two companies to a long-term, mutually rewarding relationship,” said Celsion CEO Michael H. Tardugno in a statement Monday. “It is also an example of Celsion delivering on its stated goal of licensing ThermoDox to pharmaceutical partners with the expertise and capabilities essential to market success.”
Celsion (NASDAQ: CLN) posted a third-quarter loss in November of $4.3 million.

Our technology in action

Heat-activated liposomal technology in action

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• Liposomes containing a chemotherapy agent circulate in solution throughout the bloodstream and pass into tumors through leaks in the vasculature
• Upon application of focused heat, vasculature leakage increases and the unique heat-sensitive liposome membrane dissipates, releasing chemotherapeutic drug directly into the tumor
• After drug is released into the tumor, the tumor shrinks and dies

The science of LTSL has already been reviewed and validated by major scientific institutions and investigators. The technology, further developed by Celsion, is being used to enhance existing chemotherapeutics.
The graphs below represent studies that were conducted that demonstrate ThermoDox's comparative value in delivering high concentrations of doxorubicin at clinically achievable temperatures, 39-43ºC. In vitro experiments represented in the graph below, demonstrate the rapid release of doxorubicin from ThermoDox when activated at temperatures above 39.5ºC. For comparison, the non-heat sensitive liposomal formulation shows little increase in release characteristics at similar temperatures.
http://www.celsion.com/images/chart1.jpg
(Doxil is a registered trademark of Johnson and Johnson)
In vivo experiments represented in the graph below, show drug concentration in tumors at temperatures above 39.5ºC to be substantially greater with the ThermoDox formulation when compared to either free doxorubicin or a non-temperature sensitive liposomal formulation administered to mice with tumor xenografts.

http://www.celsion.com/images/chart2.jpg



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