Tuesday, December 6, 2011

The Celsion HEAT Trial Interim Aftermath: Follow-up with Management

As a follow-up to my most recent article, I thought I would provide readers an update on some of the key questions I posed to Celsion management. Today, Dr. Borys (Chief Medical Officer) and Jeff Church (Chief Corporate Business Strategy and Investor Relations Officer) from Celsion reached out to me to to give me a quick update on some of the key questions I had.

Let me remind everyone that this is exactly why I have such high respect for the management of this company. While I no doubt have recently criticized the company, respectfully, for their recent financing and for "exhausting their benefit of the doubt allowance", I maintain that we have an extremely talented and dedicated team working on behalf of shareholders. They have their work cut out for them, as I mentioned in detail, as many milestones await their successful completion. Let's not also forget that Celsion management is a small group of individuals tasked with some extremely complicated activities and work streams spanning clinical trial execution all the way to key opinion leader (KOL) relationship building. 

That said, let's dive right into some of the questions I had and the clarification Dr. Borys and Jeff Church gave me:

Q: When was the Lan DeMets implementation decided upon, and who decided on that (company, DMC, FDA)? Was this part of the original statistical analysis plan (SAP) or was this something newly decided during the interim analysis? Did the DMC make this recommendation?
A: As I was somewhat expecting, Dr. Borys made very clear that the Lan DeMets implementation was in place well before the interim analysis, as it was pre-specified in the SPA. So, no, this was not suddenly decided upon by the DMC or the company, it was the agreed upon protocol all along with the FDA.

Q: What exactly does the company mean by "sufficient rationale" to conduct another interim look? Was a second look a specific recommendation made by the DMC on the basis of the strength of the data? Or is this entirely an assumption of the company looking at blinded data?
A: To my surprise, Dr. Borys made clear that we should not read too much into the verbiage of the PR. They clarified that the company, even before heading into the interim, was exploring conducting an additional interim look at the data. To make it very clear, the sufficient rationale did not come from the DMC. As such, I take that as meaning that we should not infer anything about the underlying "strength" of the data from the "sufficient rationale" wording.

Q: The company historically has maintained an estimated 12M time for the control arm PFS. Having gone through the interim, has the company adjusted this internal working assumption?
A: Dr. Borys re-confirmed, yet again, that he and the company stand by a 12M expectation for the control arm, even after having gone through the interim analysis. Of course, the company does not have access to any unblinded data, so to confirm, these are expectations from historical data. As I pointed out in my article, many of the models I have seen point to a median PFS time for the pooled data in the mid 20's (months). If the control arm is indeed at 12M, then it might very well be that the PFS threshold was hit at the interim, but some other factor (perhaps establishing a clear OS trend) was missing to prevent an early unblinding. I am speculating here. All I can confirm is the company still firmly stands by a 12M expectation for the control arm.

Q: What is the proposed timeline for modifying the SPA with the FDA? Has the company initiated this process already?
A: Very bluntly, Jeff mentioned that the company would announce anything involving the potential SPA amendment and interaction with the FDA. I completely understand that.

Q: What is the status of the ABLATE study? The trial has been on ClinicalTrials.gov since early November, but no PR as of yet for treated patients.
A: Dr. Borys said the trial was not "delayed" by any means. He said the some patients have been screened already, and we "should not be surprised" to hear a PR for the first treated patient by end of year.

Q: What is the company's expectation for the performance of the control arm in the ABLATE study (local recurrence at 1 year)?
A: After being put on hold for the two to discuss, they were unable to share with me their own internal guidance on this, which was a bit surprising to me. However, I don't take this to mean that they did not want to share this information, rather, my takeaway is that they are still gauging the medical literature to identify precisely their expectations for the control arm. I will eventually put a lot of focus on this issue as ABLATE gets up and running.

Hopefully, investors found this update informative.

I want to conclude by saying I was extremely excited (and beyond humbled) to learn today that Celsion CEO, Michael Tardugno, has accepted to do an interview with me that would be made available to visitors of my blog (hopefully over the next two weeks). (12/7 CORRECTION: My discussion with Mr. Tardugno is not meant to be a formal interview per se. I incorrectly mischaracterized the nature of this upcoming discussion, which will indeed still take place. That said, Mr. Tardugno invited me to send him questions, which I have already done, and he will respond to the ones that he can speak to. Understandably, full disclosure is a top priority for the company, and he made that very clear during my exchange with him) Staring at the stock price just hovering over $2, some might be tempted to think the CEO is doing "damage control" by reaching out to me. I highly doubt that, as the company has always been very transparent and accessible with questions that I have posed to them. This is obviously a much bigger forum, but nonetheless, consistent with how the company reacts to questions from their shareholder base. For that, we should all applaud Celsion management, and Mr. Tardugno.


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