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Celsion Management Discusses Q2 2012 Results - Earnings Call Transcript

And if we are right about the outcome of the HEAT Study, we have every reason to believe that we will -- believe we will be bringing to market one of the most important new drugs in a generation, that's ThermoDox. You don't have to take our word for it. Look at the support we've had from multiple regulatory agencies around the world and, in particular, from the FDA. We've negotiated an SPA. We have Fast Track. We have Orphan Designation. We have an agreement to file using a 505(b)(2) approach, and we are candidate for priority review as a function of the strength of our data. The reason for this, well, it's clear. HCC is an enormous unmet medical need.

Let's go through the facts because I think you'll agree with me, they are sobering. ThermoDox's principle indication is HCC, the world's fifth largest cancer and a disease of significant concern within the global oncology community and public health agency. Incidents is approximately 28,000 in the United States. It's tripled in incidents over the 30 year period from 1977 to 2007. There are 40,000 incidents in Europe, and is growing rapidly at 5% worldwide from a base of 750,000 new cases annually.

Over 50% of these new cases will be in China, emphasizing the importance of this market for us and a rationale for a high concentration of investigator sites in that country. The World Health Organization predicts that HCC will become the #1 cancer worldwide by 2020, surpassing lung cancer. For countries in the West and Japan, during the 10-year period ending 2019, incidents is expected to increase by 20% and prevalence by 47%. It's also clear that the evidence for a successful HEAT trial is on our side. We know doxorubicin, the anticancer agent in ThermoDox is active in liver cancer. Our drug system technology is designed to improve its efficacy in the presence of heat. We know that combining ThermoDox with RFA has shown remarkable potential in early phase studies to delay disease progression. We know that delayed progression or PFS, progression-free survival, is both sensitive and specific as a surrogate for overall survival. In our target population, median time to progression is 12 months with median time to death 30 months. Outcome statistics in this population have remained constant since we began our research into HCC over 6 years ago.

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