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Monday, March 08, 2010 10:25:37 AM
Two Final-Studies in Breast & Liver Cancer .This Undiscovered stock is the next DNDN.Market Cap of 50 M$ is wayyyyyy Undervalued ...
Celsion (CLSN)
Market Cap: 50,7 Mio$
Cash: 12,6 Mio$
Price: 4,18 $
Shares Out: 12,1 M
First drug, ThermoDox®, is in 2 registrational trials with near term commercialization
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ThermoDox addresses $ billion market potential
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Strong IP patent protection to 2018 with extension potential, Orphan Drug designation in US
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Commercialization plans maximize shareholder value
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US strategy is to market and sell directly
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Ex-US strategy is through license agreements with Pharma partners
Key Events Through 2010
Sign 2nd license agreement for ThermoDox Q2/3Q 2010
600 patients in Phase 3 HCC Trial Q2 2010
Interim Analysis Phase III Q4 2010
1st data set analysis from RCW Phase I/II trial 12/2010
"We continue to make substantive progress in our Phase III HEAT trial for ThermoDox with over 45% of the 600 patients now enrolled in the study," said Michael Tardugno, President and CEO of Celsion. "With the recent addition of China, Thailand, Malaysia, Philippines and additional sites in Korea, Taiwan and Italy, we expect enrollment completion within the next 2 quarters. We have achieved our goal of opening enrollment at 60 clinical trial sites world-wide, and we anticipate initiating the trial at an additional 10 sites by the end of this month. Additionally, our pivotal Phase recurrent chest wall breast cancer trial, the Dignity Study, has enrolled a sufficient number of patients in the Phase I portion to warrant a dose escalation review by the DSMB. Assuming there will be no adverse events suggesting dose limiting toxicity, the Dignity Study may be allowed to increase dosage to the therapeutic dose as early as March of this year."
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