Wednesday, August 3, 2011

Key Takeaways from HEAT enrollment PR

As expected, Celsion today announced that enrollment in their Phase 3 HEAT study has been completed. It's been a long-time coming, as management has had to frequently extend their estimated enrollment completion times in the past. In prior public statements, the company has said that, among other things, the hold-up in Japan, logistical challenges and the presence of other clinical trials seeking similar HCC patients in the HEAT study, have been key culprits contributing to the delays.

With that said, enrollment is now behind us. Today's press release marks a major milestone for the company. Here are some of my takeaways from the PR:
  1. We now know for sure 190 events has not happened yet (UPDATE: or 190 has not been "confirmed" yet by DMC). This either means the control arm is doing much better than the 12M expected median time management is predicting, or Thermodox is really showing some impressive results. I would be on the lookout for a PR announcing 190 events within the next 2 weeks. 
  2. Over-enrollment beyond 600 patients will happen, not just for Japan. It looks like the company will continue enrolling Chinese patients to meet the 200 required for registration. China is a major market for HCC and critical for the company. 
  3. Speaking of Japan, no comment in the PR. I will just leave it at that, but I do hope management is working vigorously behind the scenes along with their partner, Yakult, to get Japan dialed in again. Make no mistake, Japan is a critical HCC market, especially because of the country's highly efficient surveillance system that identifies patients early enough to be eligible for curative treatment such as RFA.
  4. Management appears extremely confident in Thermodox for HCC. I lost track of how many times in prior PR's Michael Tardugno, the company's CEO, has mentioned Thermodox as being a potential new "standard of care" for first line HCC therapy. This enthusiasm was once again expressed in this latest PR, and I think this bodes well for the HEAT study in general. Most significantly, Mr. Tardugno said this potential would become "clearer in the coming months", hinting at the outcome of the interim analysis. 
I look forward to the upcoming Q2 earnings conference call on Tuesday at 11AM ET for additional updates from management (You can use this link to access it:


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