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Re: mergerwithbigpharma post# 68

Saturday, 02/05/2011 12:59:28 AM

Saturday, February 05, 2011 12:59:28 AM

Post# of 16750
Why all the recent fund raising?

Feels like a pivotal quarter. Best scenario, Celsion wants a solid financial position to allow them to wait for data to mature and get better terms in a partnership.

Looking at the bar for approval based on Nexavar SHARP results.

The approval of sorafenib in 2007 for the treatment of HCC patients in both the United States and the European Union represents a true paradigm shift in the treatment of advanced HCC and is a clinically meaningful therapeutic advancement in this challenging malignancy. Interestingly, a subsequent prospective controlled trial of sorafenib in Asian patients with the same design and eligibility criteria as the SHARP trial showed an improvement in OS with a hazard ratio similar to that of the SHARP trial. However, the Asian study showed significantly lower absolute benefit (6.2 months median survival in the study arm v 10.7 months in SHARP) and possibly overall lower toler- ance of sorafenib.105 Understanding the reasons for such differential effects is essential to inform the design of future trials in HCC and underscores the importance of identifying stratification factors in future clinical trials, such as hepatic function, ethnicity, disease etiol- ogy, and tumor molecular profile.

http://files.shareholder.com/downloads/CLN/0x0x393141/dba27485-464e-4cec-a208-ca3f5d2f85de/JCO_2010_-_08-03-2010_ThermoDox_Chart_3.pdf

The second trial
226 Asian patients
median overall survival of 6.2 months for sorafenib and 4.1 months for placebo. There was also a significant 74% improvement in time to progression, with a median time to progression of 2.8 months for sorafenib and 1.4 months for placebo