Friday, September 14, 2012

Final HEAT DMC Meeting Results in Expected Unanimous Recommendation to Continue, 380 PFS Still Projected for Q4

This morning, investors woke up to a highly anticipated press release from Celsion in regards to the outcome of their regularly planned, independent Data Monitoring Committee (DMC) routine safety review for patients in the HEAT study. This was one of 7 (maybe 8, I lost count to be honest) such reviews conducted by the DMC throughout the duration of the trial, so what made this one so important? Management has mentioned in prior calls that they would update the investor community if the timing for 380 PFS events, originally estimated for "Q4" with data to follow (also in Q4) changed significantly following this DMC review.

So, what did we get in the press release?

"Celsion reconfirmed that 380 PFS events are projected to occur in the fourth quarter of 2012, with top line results announced following DMC review and confirmation."

Couple things to note about this wording from the PR:
  1. The guidance has NOT changed, this is the same thing we have heard for some time now. I take that as being status quo. Celsion CEO has stated numerous times that the company's "best guess" for top-line data is in Q4, so my assumption is they are expecting 380 PFS to be confirmed early to mid Q4, just enough time for the 8-12 week process of compiling and tabulating the data.
  2. Some might suggest the wording "opens the door" for data to bleed into 2013. It certainly IS possible, especially if 380 PFS is not confirmed until late December, as an example. 
Beyond this DMC PR, I know many (voiced loudly by many I interact with on twitter) WILL want to know exactly when 380 PFS is eventually confirmed in Q4. Perhaps this will be something the company speaks to during the Q3 quarterly call (likely in early November) and reiterates in upcoming SEC filings. Not for myself (still long my original shares, holding thru data, makes no difference to me), but for the sake of traders who want to plan and execute their trading strategies leading up to final data, I also do hope the company gives some more clarity on when the 380 has been confirmed. Not to worry, all of this really is a "timing" game. Worst case scenario, 380 PFS occurs on New Year's eve, and we get data in February.
The outcome of the HEAT study looms, and as Adam Feuerstein points out today in his latest mailbag, Celsion is either "uncared" for or "unknown" to Wall Street. As I have said before (one of several reasons Celsion was attractive to me in the first place), I suspect the latter, but we will ultimately have to wait for final data to make that determination. 



  1. what is your take on the breast cancer phase 1/2 data due in the beginning of Oct? Will this be anything new i.e. taken as a precursor to the phase 3?

  2. I think the Phase I/II RCW data will simply be a confirmation of ThermoDox's clinical utility, confirmation of its use with various heating sources (ie micrwave hyperthermia versus RFA in the HEAT study), and an indication of its broad applicability. The ESMO abstract was recently released, and what is very interesting is that most of the patients had failed prior anthracyclines. That makes the 45% ORR (which includes 1 CR) that much more impressive.

    To be clear, this does not portend anything about the HEAT study's chances for success. Whole different indication and endpoint. But it is timely data nevertheless, and from the look of the recent strength in the SP, I would argue the RCW data has been well received. Also, while the specific line of therapy for RCW (3rd/4th line of therapy) is a relatively small market, these patients receive 4-6 cycles of ThermoDox, so on a per patient basis, the potential revenue is much higher than HCC.

  3. "Celsion reconfirmed that 380 PFS events are projected to occur in the fourth quarter of 2012, with top line results announced following DMC review and confirmation."

    Do you think the timeline for this has moved UP...They consistently have said "late q4"...

    Maybe I am reading too much into the verbiage?? Thoughts?