Celsion Corporation (CLSN)

[sdtrond]

No-dough seems to answered the six month question thoroughly.

I'm too wrapped up in the story, not sure where this six month thing even came from. Mgmt has insisted from the trial construction that expected PFS for the placebo arm is 11-12 months. And as recently as the last CC they affirmed 12 months from the literature.

The problem is that liver cancer is very varied. Lots of things interact, size & # of tumors, Child-Pugh, even how close the tumor is to major veins. There are quite a few trials but almost none are apples to apples.

I brought this up in a conversation with MT a year or so ago and he agreed - that HEAT is pretty much going to be THE definitive trial going forward for RFA comparisons. We were among the largest ever HCC trials w/ 600 and now that its expanded to 700 it might be THE largest. With arms 1:1 that is 350 RFA patients, stratified by tumor size and ablation type.
KEY take-away: all other trials vs RFA will have to surpass Themodox's performance if good!

More precisely to the original point, Karin had it right that HEAT is RFA-alone vs. RFA+TDox. RFA works, and is "curative" for smaller tumors that are amenable to RFA (20-35%ish of the HCC indication). But local progression frequently occurs because of micromets that left behind in the ablative fringe. TDox should help immensely in keeping local reoccurance from happening. That leaves progression elsewhere in the liver or outside the liver as the main things to worry about, and they WILL happen. Just not as timely.

I'm a bull, but eyes open - the distant mets issue is real. But size of trial, size of ph1, and similar "problems" are red herrings.