Celsion Corporation (CLSN)

[cameron12x]

Here are two very telling articles:

Part I
Part II

("Biotech Sage" is a very educated (PhD) biotech hedge fund investor.)

I read through both articles and I also completely read through over 200 comments (his, and other posters). He brings up a LOT of very good points, which were later borne out when he accurately predicted the P3 failure.

There are two major takeaways which are VERY telling to me:

1. Only (9) patients had HCC and only (1) patient in the original 24-patient P1 trial had a non-resectable HCC tumor greater than 3cm in size. A sample size of (1) as the basis for a fast-tracked clinical trial of 700 patients with tumor sizes between 3cm and 7cm? That seems preposterous, but maybe the FDA was looking at just the pre-clinical animal studies? To repeat, a P1 sample size of (1) for the tumor size range (3cm - 7cm) enrollment in the P3 trial? The P3 trial seemed destined to fail based on the incredibly small P1 sample size of (1) alone.

2. The data cited from Celsion's own presentations seemed to indicate that most of the TDOX wouldn't even have accumulated in the liver until at least one hour had passed, yet RFA was applied beginning 15 minutes after the original infusion? Now why did they make that apparent mistake by apparently starting the RFA too soon!?

The subsequent post-hoc data seems to corroborate the fact that maximum benefit did not occur until RFA was applied for at least 45 minutes. (And I suspect that even more benefit would be found if even longer RFA times are used, as more of the TDOX will have had time to accumulate in the liver.) If Celsion had looked at their own data more closely, they'd have known that in advance and would not have blown the P3 trial by starting the RFA too soon and for not applying it for a long enough duration. Sheesh.

Perhaps they learned as the trial unfolded that they needed the longer RFA ablation times, and that is what led to the extended enrollment periods?

Whether the FDA and/or CFDA will take a look at the possible later subgroup patient enrollment cohorts with seriousness (e.g. statistical significance) is the BILLION dollar question. It's questionable, at best. Unfortunately, I believe there is a high probability that the FDA will want a new trial, and that no regulatory approval will come from HEAT.

But there is always "hope."